Source: https://xendo.com/careers
Timestamp: 2019-04-20 14:32:08+00:00

Document:
Our ambition is to enhance the quality and safety of medicines and help shorten the time to market for drugs and medical devices that improve the quality of life. Working alongside smart and driven colleagues, you can make a lasting impact on our customers, the industry and patient health around the world. Within a consultancy environment, knowledge and experience are important, but we also welcome people who are just embarking on their career. We provide a culture where being result-driven, enthusiasm and being passionate about your job are equally important.
As a Graduate in Molecular Life Sciences, Angie is fascinated by science in general and its importance and contribution to human health. She has a proven track record in science and strong communication skills, she is also comfortable with new environments, tasks, and working with many different types of individuals; making her an ideal candidate for our Young Talent program. Currently, she is active in our Adverse Event Managment team while increasing her expertise with a Masters in Pharmacovigilance.
Joost has a background in Mechanical Engineering and has been involved in data management and validation on a personal level as well. Following an internship at Xendo he started as a Quality Engineer in which function he developed several services like asset management and computer systems validation and is now one of our longer-serving employees.
Currently working as managing consultant, he has built up his own team surrounding these services and is successfully executing a wide variety of projects and is also a board member of the local ISPE GAMP-COP.
With a background in medical biology, Liesbeth worked in big pharma for over 10 years. During these years she was actively involved in the development and execution of global regulatory strategies across therapeutic areas. She truly enjoys working as a consultant as it allows her to bring in her regulatory knowledge and wide range of experiences towards Xendo and towards the clients. It is a pleasure for her to work with the clients, being in direct contact with them and contributing to their product life cycles whether it involves hands on work or strategic advice.
I am Marc Stegeman and I work as a Principal Consultant and Black Belt with Xendo. I very much enjoy my work as a consultant. It brings together all my experience gained as a specialist and manager in QA, regulatory, Lean Six Sigma and manufacturing. Most of this type of work I did in previous jobs, at one company, at one site. Today, this context has been expanded while doing this work at different places, at different customers with different interests and moods, but in one week.
Camilo Molina started his career at Merck Sharp & Dohme in Colombia, where he supported the regulatory submissions to the local authority and also managed data of clinical study visits. He also worked in R&D developing new cosmetic formulations. To pursue new challenges and to experience different cultures, he came to Germany and decided to stay. At Xendo he got engaged in new IT solutions within regulatory intelligence and works as a RA Project Manager. Additionally, he is a part of the Xendo eCTD core team helping clients creating sequences.
Xiaoxi brings her passion of science into the regulatory affairs field and uses her expertise in analytics to help our clients to develop their biological and biosimilar products. With the believe that science is not limited to the lab, she brings in her research experience to scientific advice procedures, IMPD and CMC writing.
During her life, she moved from China to the USA and Germany and Xiaoxis understanding of multi-cultural backgrounds explains her success in leading international projects. During her time at Xendo, Xiaoxi expanded her regulatory knowhow by certified project management skills. She especially enjoys working in our international and open-minded company.
Xendo, a ProPharma Group company, is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare. Thanks to our multi-disciplinary, knowledge-driven approach, we deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. ProPharma Group combined with Xendo has more than 1,000 professionals worldwide providing an unmatched variety of compliance related services including medical information, pharmacovigilance, clinical safety, regulatory affairs, and a continuously expanding range of compliance, quality assurance, validation, and consulting services; providing a full-colour spectrum.
As a Managing Consultant, you will be the first point of contact for all questions of our clients´ questions and requests with regard to pharmaceutical regulatory requirements and strategies. Our client spectrum includes large and small companies in the pharmaceutical industry.
You will be responsible for maintaining existing client relationships as well as establishing new business opportunities in line with the service portfolio.
You will effectively lead and further develop your team to maintain a high level of service for our clients.
You will be responsible for budget planning and ensure that revenue targets are achieved.
You hold a university degree, preferably in Life Science, Chemistry, Pharmacy or related disciplines.
You have extensive experience in Regulatory Affairs within the Pharmaceutical industry, with a sound knowledge of relevant national and international regulatory requirements. In addition, you are willing to continuously learn and expand your knowledge in this area.
You have experience in managing projects and leading a team.
You possess strong analytical and organizational skills as well as problem-solving and consulting competence.
You have an excellent command of written and spoken German and English.
You have very good MS Office skills.
You are willing to travel to clients and other business locations.
We are an equal opportunity employer. M/F/D/. If you are qualified and are interested in our position, please send us your complete application to . In case of any questions, please do not hesitate to get in touch with us. We are looking forward to your application.
The Engineering & Technical Support Division is expanding its engineering team with a Facility Engineer. Are you an experienced engineering professional looking for challenge and growth, then this might be your chance!
Xendo, a ProPharma Group Company, is a consultancy and project management organization in the (bio) pharmaceutical, medical devices and healthcare fields. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right color to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, most established multinational companies and organizations.
Facility Engineering team within the Engineering & Technical Support Division, reporting to the Managing Consultant.
Those who are familiar with typical utility installations like HVAC, Purified water, Clean Compressed Air, CO2, LN2 and building-related installations like cold rooms. We are involved in project s which involve the Engineering and Qualification of commercial GMP manufacturing sites in the Netherlands. Scope of contract is the management and execution of all Qualification activities (URS, Risk Assessments, System Impact Assessments. DQ, IOQ and PQ) of all equipment (QC and Manufacturing) and all direct impact utilities.
As a Facility engineering, you will be responsible for the executing of engineering tasks within one or more projects with a medium lead time (0.5 – 1 year). You will manage engineering projects individually and within a multi-disciplinary team where you will have great influence and responsibilities. Your assignments will vary from conceptual or basic design of new laboratories or manufacturing facilities to consultancy and advice on maintenance management and improvement of maintenance planning as well as technical audits. All work undertaken needs to be in accordance with the agreed budget, timescale, quality and performance criteria within the required procedures (health and safety, GMP, local and corporate standards). At times you will work at the premises of our clients, but also from the Xendo office in Leiden. With your extended experience in facility engineering and preferably project management you would be considered a great and valuable asset to our company. The Sr. Facility Engineer will report directly to the Managing Consultant Facility Engineering.
Solid engineering (5-7 years) experience with specific experience within (bio) pharmaceutical (or related industries) and GMP is desirable.
Proficient in English language, both in speaking and in writing. Good command of a second language is an advantage.
Please contact Paul Zantingh, Talent Acquisition Manager at +31 71 524 40 00 or by e-mail for additional information about job specifics.
projects at both small and large life science organisations and suppliers.
Are you interested in an independent and responsible position in a growing organisation with the opportunity to develop yourself? Then this might be your chance! Within our Division Compliance & Validation, we are recruiting for people experienced in a wide range GMP areas: Quality Assurance, Quality Control and Qualified Persons (QP and/or RP) who are ready to enter the world of consultancy.
Xendo, a ProPharma Group Company, is a consultancy and project management organization in the (bio) pharmaceutical, medical devices and healthcare fields. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right color to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, most established multinational companies and organisations.
Usually, the work takes place at the clients’ site and entails working in a team of specialists in which related topics such as active substance, drug product, quality, and regulatory aspects are discussed.
Currently, our teams are involved in the development of an even broader range of services to support our customers in improving their processes. As a new team member, you are challenged and invited to bring forward your expert ideas to contribute to these new or improved services.
For this role, we are looking for candidates with solid experience (4-6 years) in GMP related areas in QA and QC in the life science industry, having experience in development (R&D) is a plus. Also being or having worked as a QP is plus.
It is expected that you are able and willing to dig into the details yet keeping an eye on the overall goal of the project. You are result- and client oriented and have adequate interpersonal skills. You feel comfortable working with deadlines in an often changing environment and see it as a challenge to solve issues in a pragmatic and proactive way.
Hands-on knowledge and experience in one of the given GMP area’s.
An environment, which strives for high quality, continuous improvement, and knowledge sharing.
As a Managing Consultant, you will be the first point of contact for all our clients’ questions and requests with regard to the development and maintenance of quality management systems. The regulatory standards our clients work with include GDP, GMP, GCP, ISO9001, and ISO13485. Together with your team, you will help clients apply for licenses as well as accompany them through audits, inspections and certification processes. Our client spectrum includes large and small companies in the pharmaceutical and medical devices industry.
You will be responsible for maintaining existing client relationships in line with the service portfolio.
You will take over the function of “Responsible Person” according to §52 an AMG or as ”BtM Responsible” according to §5 BtMG or as “Qualified Person” according to §14 AMG or as Quality Management Representative for our clients.
help clients to identify processes that require quality management measures within their organisations build and maintain quality compliant systems/processes for clients.
prepare the necessary SOPs in accordance with the legal requirements and applicable standards.
prepare or review quality agreements.
conduct audits and coordinate inspections with the authorities for clients.
submit applications for dealer licenses or narcotics license on behalf of the clients as well as support and advice contract manufacturers /CMOs.
advise clients on quality issues and ensure compliance/implementation of quality guidelines.
You hold a university degree in Life Science, ideally in Pharmacy.
Ideally, you already held the functions as “Responsible Person” according to §52 AMG or as “BtM Responsible” according to §5 BtMG or as a “Qualified Person” according to §14 AMG or have professional experience as a Quality Management Representative.
You have several years of experience in quality management at a pharmaceutical company, a contract manufacturer organisation or a medical device manufacturer.
You have a sound knowledge of relevant national and international standards and guidelines in the pharmaceutical and medical device law. In addition, you are willing to continuously learn and expand your knowledge in this area.
You have a good command of written and spoken German and English.
You have very good communication and negotiation skills.
You are ready/open to travel to clients and other Xendo sites.
If you are interested in this position, please send your complete application to Vivian Maumo-Ney: In case of any questions, please do not hesitate to get in touch with us. We are looking forward to your application!
Xendo, ein Unternehmen der ProPharma Group, ist ein Beratungs- und Projektmanagement-Unternehmen in den Bereichen (Bio-)Pharma, Medizinprodukte und Gesundheitswesen. Dank unseres multidisziplinären, wissensbasierten Ansatzes kann Xendo eine breite Palette von Dienstleistungen für die Life-Science-Industrie anbieten. Seit über 25 Jahren haben wir Tausende von nationalen und internationalen Projekten für Start-ups sowie für große und etablierte multinationale Unternehmen und Organisationen erfolgreich abgeschlossen.
Als Managing Consultant berichten Sie direkt an die Geschäftsführung und sind der erste Ansprechpartner für alle Fragen und Anliegen unserer Kunden zur Entwicklung und Aufrechterhaltung von Qualitätsmanagementsystemen. Zu den regulatorischen Standards, mit denen unsere Kunden arbeiten, gehören GDP, GMP, GCP, ISO9001 und ISO13485. Gemeinsam mit Ihrem Team unterstützen Sie Kunden bei der Beantragung von Lizenzen und begleiten sie durch Audits, Inspektionen und Zertifizierungsprozesse. Zu unserem Kundenkreis gehören große und kleine Unternehmen der Pharma- und Medizinprodukteindustrie.
Sie pflegen bestehende Kundenbeziehungen und entwickeln unseren Kundenstamm aktiv weiter.
Sie sind für die fachliche und disziplinarische Führung und Entwicklung des QA-Teams verantwortlich.
Sie entwickeln und implementieren Qualitätsstrategien zur Erreichung der Unternehmensziele.
Sie planen das Jahresbudget und gewährleisten dessen Erreichung.
Sie erstellen Angebote für die Kunden.
Sie übernehmen die Funktion als „Verantwortliche Person“ nach §52a AMG oder als „BtM Beauftragter“ oder als „Sachkundige Person“ nach §14 AMG oder als Qualitätsmanagementbeauftragter für unsere Kunden.
Kunden bei der Identifizierung von Prozessen, die Qualitätsmanagement-Maßnahmen in ihren Unternehmen erfordern, unterstützen.
Kunden bei dem Aufbau und der Aufrechterhaltung qualitätskonformer Systeme/Prozesse unterstützen.
Relevante SOPs in Übereinstimmung mit den gesetzlichen Anforderungen und den geltenden Normen erstellen.
Behördeninspektionen und Audits von Kunden und Lohnherstellern vorbereiten.
Anträge für Händlerlizenzen oder Rauschgiftlizenzen für Kunden stellen sowie Vertragshersteller /CMOs unterstützen und beraten.
Kunden in Qualitätsfragen beraten und die Einhaltung/Umsetzung von Qualitätsrichtlinien sicherstellen.
Erfolgreich abgeschlossenes Universitätsstudium in den Naturwissenschaften, idealerweise in Pharmazie oder vergleichbar.
Im Idealfall haben Sie bereits die Funktionen als „Verantwortliche Person“ nach §52a AMG oder als „BtM Beauftragter“ oder als „Sachkundige Person“ nach §14 AMG ausgeübt oder verfügen über Berufserfahrung als Qualitätsmanagementbeauftragter.
Sie verfügen über mehrjährige Erfahrung im Qualitätsmanagement in einem Pharmaunternehmen, einer Auftragsfertigungsorganisation oder einem Medizinproduktehersteller.
Sie haben bereits Erfahrung in Projekt – und Teamleitung.
Sie verfügen über fundierte Kenntnisse der relevanten nationalen und internationalen Normen und Richtlinien im Pharma- und Medizinprodukterecht. Darüber hinaus sind Sie bereit, Ihr Wissen in diesem Bereich kontinuierlich zu erweitern.
Sie verfügen über gute Kenntnisse in Wort und Schrift in Deutsch und Englisch.
Wenn Sie sich für diese Stelle interessieren, senden Sie bitte Ihre vollständige Bewerbung an Vivian Maumo-Ney: . Bei Fragen stehen wir Ihnen gerne jederzeit zur Verfügung. Wir freuen uns auf Ihre Bewerbung!
Xendo is a leading consultancy and project management organisation in the fields of (bio) pharmaceutical products, medical devices, and healthcare. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.
Over 240 experienced and highly educated professionals offer their expertise ranging from strategic advice and project management to auditing, operational support, and training; providing a full-colour spectrum. They do so from our headquarters in the Netherlands or offices in Germany and Sweden.
You, ideally hold a Ph.D. in Pharmacy, Biology, Veterinary or Human Medicine.
You have proven experience in Regulatory Affairs or Medical Writing.
You are good in writing scientific and technical texts.
You are ready to take over the role of Information Officer for clients.
You are able to maintain high quality, accuracy and consistency in your work and deliver on your commitments.
You are able to work independently with less supervision, take initiative and make decisions based on company guidelines.
You are able to work on multiple projects, prioritize and meet project deadlines.
You are an excellent communicator and have the ability to work with all levels of the company.
You can transfer knowledge to others and teach them abilities based on a coherent educational programme.
You are well organized and pay attention to detail.
You have outstanding German and English skills.
Are you interested in an independent and responsible position in a growing organisation with the opportunity to develop yourself? Then this might be your chance! Xendo is looking for an experienced Senior Consultant with Medical Safety & writing experience.
The work is performed on a global level. Our office is located in Leiden where the QPPV & Medical Safety Science team is based, but it is an option to work from home as well.
The Medical Safety Science Team consists of a team of experts with very broad experience in analyzing and evaluating data and writing of required periodic reports. The main focus of the team is on report writing (DSURs, PSURs/PBRERs, (development) RMPs), risk and signal management, global literature assessment and providing consultancy or training for clients in the aforementioned areas, both in pre-approval and post-approval phase. The Senior Consultant reports to the Managing Consultant.
This role is a challenging position for someone with at least 5 years’ experience within PV including 2-3 years of Pharmacovigilance medical writing experience; with a main focus on the EU. Preferably you also have work experience within a pharmaceutical company and/or regulatory authority in the area of pharmacovigilance.
The Senior Consultant is responsible for writing, reviewing and controlling the quality of safety reports such as DSURs, PSURs/PBRERs, PADERs, RMPs, Benefit-Risk Evaluation reports, signal detection reports, and other safety reports requested by clients. Other tasks are analyzing of safety data and other data relevant for safety reports. The Senior Consultant is involved in project management, communication with clients, writing of SOPs relevant for medical safety writing attending audits and inspections as required and providing client-specific training or training for colleagues as required. Other types of consultancy can also be part of the role, depending on the profile and experience of the consultant.
PhD, MD or MSc University degree in Life Sciences (e.g. biology, biochemistry, physiology or chemistry) or related fields e.g. equivalent medical qualifications or nursing is preferred.
Knowledge and/or understanding of PV, PV legislation and guidance, scientific and/or medical knowledge and knowledge of MedDRA.
Are you a starting RA professional and looking for career growth?
As a result of the continuous growth of our company and the Regulatory Affairs Division we are looking for a starting professional who like to expand his/her experience in Regulatory Affairs by working in a challenging role as an (associate) consultant RA.
For 25 years Xendo is a leading consultancy organization for the (bio) pharmaceutical industry, medical devices and Life Sciences industry, based near the Bio Science Park in Leiden. In recent years Xendo successfully delivered projects for more than 400 clients. Xendo has an excellent international reputation as a consultancy organization. Most of the work is performed in the Netherlands, Germany and the Nordic Countries, but also on an EU and Worldwide level. Our expertise lies in Regulatory Affairs, Pharmacovigilance, OPEX/Quality Management, Engineering, Qualification & Validation, Product Development and E-Compliance & Data Management.
Being a consultant you will have the opportunity to work in a wide variety of projects and companies. Assignments may cover all aspects of regulatory affairs ranging from pre-approval and scientific advice meetings to regulatory maintenance, from CMC to regulatory project management and from work on small molecules to high-tech (biological) products.
You are an entrepreneur, able to think and act at a scientific level, who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. At least 1-3 years of experience in regulatory affairs within the pharmaceutical industry or government agency is a requirement.
With these experience you are curious about new opportunities for yourself, the client and Xendo, a self-starter and quick learner with excellent communication skills. Your Dutch and English are fluent.
You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of changes in this area on the products or portfolio of your customers.
If this profile fits to you and the above environment interest you we encourage you to apply.
We invest in our employees. Such as level-raising courses, subject-specific training courses or courses aimed at personal development. That is good for you and also good for us, when you broaden your knowledge and expertise. There are chances to grow to a higher position means in the first place that you get more responsibility, but your job content also can sometimes change completely. We certainly encourage you to take advantage of all the opportunities you get and show initiative in this.
Are you interested in an independent and responsible position in a growing organisation with the opportunity to develop yourself? Then this might be your chance! Xendo is looking for an experienced (sr.) consultant in the Life Sciences industry within the Development & Manufacturing team (D&M).
Xendo is a consultancy and project management organisation in the (bio)pharmaceutical, medical devices and healthcare fields. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, most established multinational companies and organisations.
The D & M Team, which is part of the Compliance & Validation Division consists of a team of experts with broad experience in development, manufacturing and tech transfer of (bio)pharmaceuticals. The (sr.) consultant reports to the Managing Consultant of the team.
This role is a challenging position for someone with a minimum of 5 years of experience in pharmaceutical development including considerable knowledge of GxP requirements along the development life cycle.
The (sr.) consultant will support diverse projects at our clients. Your responsibilities include setting up development, tech transfer and manufacturing projects, monitoring timing and costs and progress reporting on deliverables. The (sr) consultant will execute these task based on his/her expertise in this field.
You will also contribute to the growth of Xendo by building and maintaining relationships with new and existing clients and identifying opportunities with clients.
An extensive development programme for hard and soft skills.
As a result of the continuous growth of our company and the Regulatory Affairs Division we are looking for an experienced professional who like to expand his/her experience in Regulatory Affairs by working in a challenging role as (senior) consultant RA with a coaching function to junior colleagues in a project management setting.
For 25 years Xendo is a leading consultancy organization for the (bio) pharmaceutical industry, medical devices and Life Sciences industry, based at the Bio Science Park in Leiden. In recent years Xendo successfully delivered projects for more than 300 clients. Xendo has an excellent international reputation as a consultancy organization. Most of the work is performed in the Netherlands and Germany, but on an EU and Worldwide level. Our expertise lies in Regulatory Affairs, Pharmacovigilance, OPEX/Quality Management, Engineering, Qualification & Validation, Product Development and E-Compliance & Data Management.
Depending on your expertise, experience and interest you will be assigned to customers looking for hands-on support and/or requiring advice on regulatory strategic issues. The duration and size of the projects can vary from months to years, from 5 days a week to a couple of hours a month and from working at your own home to the office of the customer. Besides you will be the coach for associate regulatory affairs consultants and keep track of their work within in the different projects.
You are an entrepreneur, able to think and act at a scientific level, who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. At least 5-7 years of experience in regulatory affairs within the pharmaceutical industry or government agency is a requirement.
You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are also well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of changes in this area on the products or portfolio of your customers.
Xendo's German office in Berlin is looking for a new colleague to join the RA CMC team. Specifically, we're looking for someone who enjoys engaging in different projects in the pharmaceutical industry and to assist our clients in fulfilling their business needs. If you have experience in a this (or a similar) field, are open minded, result- and solution-oriented and possess good interpersonal skills, please contact us.
You, ideally hold a D. in Chemistry, Biochemistry or Pharmacy.
You have proven experience in the pharmaceutical industry in roles such as Product Development, Manufacturing, Quality or Regulatory Affairs.
You have an excellent understanding of the pharmaceutical product lifecycle.
You have extensive experience in preparing documentation for regulatory authorities.
You are able to maintain high quality, accuracy, and consistency in your work and deliver on your commitments.
You are willing to undertake business travels to clients and other Xendo sites.
You have excellent German and English skills.
Are you interested in an independent and responsible position in a growing organisation with the opportunity to develop yourself? Then this might be your chance! Xendo is looking for an experienced pharmacovigilance professional with managerial experience that wants to further build the QPPV & Medical Safety Science team combined with the option to carry out own assignments for clients as well.
Xendo is a consultancy and project management organisation in the (bio)pharmaceutical, medical devices and healthcare fields. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, most established multinational companies and organisations.
The pharmacovigilance division became part of Xendo in 2013 and the work is performed on a global level. You are located in our office in Leiden where the majority of the QPPV & Medical Safety Science team is based, with the option to work from home as well.
The QPPV & Medical Safety Science Team consists of a team of experts with very broad experience in analyzing and evaluating data and writing of required periodic reports. Next to the fulfillment of QPPV roles fro MAHs, activities in this team have a main focus on report writing (DSURs, PSURs/PBRERs, (development) RMPs), risk and signal management, global literature assessment and providing consultancy or training for clients in the aforementioned areas, both in pre-approval and post-approval phase. The Managing Consultant reports directly to the Director Pharmacovigilance and is part of the PV management team, where you are a key player in the determining the strategy for the PV division and its services.
This role is a challenging position for someone with extensive experience in leadership and pharmacovigilance.
The Managing Consultant leads the team of consultants and coordinates the planning of projects and reviews workload for all direct reports. Your line management responsibilities include performance appraisals, training, professional development, hiring and coaching. You will contribute to the growth of Xendo by building relationships with new and existing clients, identifying opportunities with clients and develop, together with your team of Consultants, new services the future. You provide oversight and guidance on organisational goals and company objectives. In addition to line management responsibilities, you also carry out your own assignments.
The Engineering & Technical Support Division is strengthening its process engineering team with a process and mechanical engineer. If you are an experienced professional with a proven track record in process equipment and/or mechanical engineering, then this might be your chance!
Xendo is an engineering, consultancy and project management organisation in the (bio)pharmaceutical, medical devices and healthcare fields, meaning that your clients are operating in the life science sector. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, most established multinational companies and organisations.
(Bio) Process Engineering, reporting to the Managing Consultant.
We want people who value continuous learning and who always look for ways to improve further. It is important to us that you can inspire and motivate others by giving regular and constructive feedback for both your own performance and on the performance of others. We promote a working environment based on cooperation and respect and encourage an atmosphere that fosters creativity and innovation. This role is a challenging position for someone with both technical skills and demonstrated consulting skills. We enable you to develop these skills while delivering solutions to the challenges of our clients.
The successful candidate for this position will be able to take a project from the conceptual stage through to completion, taking into account budgeting and operational considerations.
Based on your (bio)process engineering experience you develop conceptual process designs for manufacturing facilities for biopharmaceutical products. You can size and specify both upstream and downstream process equipment to enable the safe and GMP-compliant production of virus vaccines, monoclonal antibodies, therapeutic proteins etc.
You support the procurement of the process systems from a technical perspective and supervise the construction of the equipment, both at vendor premises as well as the manufacturing site. You manage, support, or execute commissioning and qualification of the systems. These activities generally take place in a Xendo team either at the Xendo office or at the client’s facilities.
Please contact Paul Zantingh, Talent Acquisition Manager at +31 71 524 40 00 or by e-mail for additional information on job specifics.
An extended development programme on hard and soft skills.
Will you seize the opportunity to work with and lead an established team that has a proven track record in the area of quality assurance? Are you looking for an intellectually challenging job with a lot of responsibility, independence and career possibilities in the field of quality assurance? Then this might be your chance!
The division Compliance & Validation is searching for a Managing Consultant. If you are a leader and have a passion for serving others, then we would like to hear from you.
Those who make the difference – in the way they act, collaborate and lead. As a Managing Consultant you will have the opportunity to share your extended knowledge in the field of quality assurance with Xendo’s clients and to closely collaborate with colleagues across divisions. Addressing new challenges and finding innovative solutions is your prerogative.
The Managing Consultant leads the Quality Assurance team, coordinates the planning of projects, and reviews workload for all direct reports (Young Talents and (Associate, Senior) Consultants). Your line management responsibilities include performance appraisals, time sheet approval, training, professional development, hiring, and coaching. You will contribute to the growth of Xendo by building relationships with new and existing clients, identifying opportunities with clients, and developing, together with your team of consultants, new services for the future.
You provide oversight and guidance on organisational goals and company objectives. In addition to line management responsibilities, you also carry out your own assignments within the scope of the Quality Assurance team.
This role is a challenging position for someone with extensive experience and a proven track record in Quality Assurance. The ideal candidate also demonstrates management and consulting competencies such as people and change management, programme management, business process design, transformation and employee processes.
Excellent proficiency in the English and Dutch languages.
The Principal Consultant Business Development strengthens Xendo’s market position, reputation and achieves further growth of the business, both for extending of our existing services as well as for product development. Together with the Division Director Pharmacovigilance the Principal Consultant Business Development Pharmacovigilance defines long-term pharmacovigilance strategic goals, builds key customer relationships, identifies business opportunities, negotiates and closes business deals, maintains extensive knowledge of current and upcoming market conditions and business critical regulatory intelligence.
The Principal Consultant Business Development reports to the Division Director Pharmacovigilance and is part of the PV management team.
The Principal Consultant works with the Division Director Pharmacovigilance and Pharmacovigilance (Managing and Senior) Consultants, and cross-functional with other Division Directors and Country Managing Directors to increase sales opportunities and thereby maximize reputation and revenue for Xendo. To achieve this, in addition to consolidating and extending our customer base, new potential customers need to be identified and targeted, Xendo’s palette of opportunities proposed to them, to ultimately converted these into packages taken up by these clients, and continue to grow business in the future.
The incumbent will also help manage existing clients and ensure they stay satisfied. The Principal Consultant Business Development will call on clients, often being required to make presentations on solutions and services that meet or predict their clients’ future needs.
The primary responsibility of the Principal Consultant Business Development Pharmacovigilance is to entice new clients and bring in new assignments and pharmacovigilance services by networking, calling, social media usage, active participation in congresses and events or other means of generating visibility and interest from potential clients and actively expand current relationships and partnerships. You will operate as the lead point of contact for any and all matters for specific pharmacovigilance accounts and will maintain and build strong, long-lasting customer relationships. You will lead and take ownership for RFP processes from request to contract implementation.
The Principal Consultant Business Development Pharmacovigilance works Division Directors, COO, Country Managing Directors, Principal Consultants, Managing Consultants, Senior Consultants and Business Support.
Prospect for potential new Pharmacovigilance clients exploring opportunities and turn this into increased and profitable business.
Set up meetings between client decision makers and Xendo senior management.
Plan approaches and pitches. Develop proposals that speaks to the client’s needs, concerns, and objectives.
Present an image based on Xendo’s unique selling points that mirrors that of the client.
Present to and consult with senior management on business trends or trendsetter ideas with a view to fine-tune existing services and products or developing new services and products based on market demand.
Identify opportunities for campaigns and services that will lead to an increase in sales.
Call as appropriate within your market or geographic area to ensure a robust pipeline of opportunities. Meet potential clients by growing, maintaining, and leveraging your network.
Using knowledge of the market and competitors, identify and develop Xendo’s unique selling propositions and differentiators.
Present new (cross divisional) products and services and enhance existing relationships.
Work with internal colleagues to meet customer needs.
Ensure that data is accurately entered and managed within the Xendo’s CRM system.
Forecast sales targets in collaboration with Division Director Pharmacovigilance and ensure these are met.
Track and record activity on accounts and leads to close deals to meet these targets.
Develop a thorough understanding of the people and capabilities cross divisions.
Networking, Persuasion, Public Speaking, Research, Writing, Closing Skills, Motivation for Sales, Prospecting Skills, Sales Planning, Identification of Customer Needs and Challenges, Market Knowledge.
As an experienced (Senior) pharmacovigilance auditor you will be responsible for managing and executing the Xendo pharmacovigilance (PV) audit programme you will be conducting audits across the entire range of PV relevant activities, with primary responsibility for planning and participating in global PV audits. The breadth of audits performed include the end to end PV system including PV system key elements, PV QMS , service providers, internal and affiliate audits on behalf of Xendo clients.
Xendo is a consultancy and project management organisation in the (bio) pharmaceutical, medical devices and healthcare fields. Our clients are predominantly operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo delivers a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. Our Pharmacovigilance Division that is a legacy of the Vigilex Company became part of Xendo in 2015 The work in this division is performed on a national, EU and Worldwide level.
Audit team within the Pharmacovigilance Division, reporting to the Managing Consultant of the team.
Those who dare to make the difference – in the way they act, collaborate, advise and lead. We are looking for a highly motivated and experienced professional who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your clients and the ability to adjust to these needs and function as a partner and advisor to the client is essential. You need to have a pharmacovigilance, medical or paramedical background or a degree in life sciences in combination with a solid knowledge of international pharmacovigilance regulations and guidelines. At least 5-10 years of experience in various roles within pharmacovigilance area or within the pharmaceutical industry with safety related roles, government agency or a PV consultancy organization is an absolute requirement. Audit experience is required and QPPV experience is preferred.
Being a Xendo Auditor you will have the opportunity to work in a wide variety of projects for different companies. This position as (senior) consultant is for the auditors team of the Pharmacovigilance division. Your audit activities will cover the entire range of PV processes, including from inspection support of our clients, Mock Inspections/ HQ audits, local affiliates/partners/vendors or tailored to a specific PV process. For our various longstanding clients, audit project management and maintenance of a good client relationship will also be an important part of your work. Training clients’ staff on PV regulations or assist in inspection preparations may also be part of your role. Our team is multinational, with several team members working home-based full time.
You may also be assigned as (deputy) QPPV to one or more clients. This concerns mainly smaller and medium-size companies, who often have a PV system under development or are undergoing major changes with (initial) marketing authorization applications. Your input as PV expert is key to these clients, but in addition we also consider (deputy) QPPV work experience a great asset to our auditors’ qualifications as they are through this role involved in all pharmacovigilance relevant processes and procedures of the client.
Please contact Helena van den Dungen, Director Pharmacovigilance at +31 71 524 40 00 or by e-mail for additional information on job specifics.
If you are interested in this position, we encourage you to send your motivation and CV to us.
As a Senior Consultant of the Engineering & Technical Support Division you will often have a detailed project contract with the client, specifying your activities and the expected results. You will predominantly work on location, but also from home or from Xendo’s Leiden office. Project’s duration can vary from one week (for high level advice/gap analyses) to several months. In short: you feel comfortable in a position that allows you to apply and further increase your knowledge and expertise in the area of GxP compliance and validation. This, amongst others, is your contribution in aim to provide better products for patients.
Xendo is a consultancy and project management organisation in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.
IT & Automation within the Engineering & Technical Support Division, reporting to the managing consultant.
Those who dare to make the difference – in the way they act, collaborate and lead. As Senior Consultant you will have the opportunity to share your extended knowledge in the field of IT & Automation with Xendo’s clients and closely collaborate with colleagues across divisions. Addressing new challenges and finding innovative solutions is your prerogative. Mostly working on-site, at the client's premises, you welcome independent responsibility for your projects.
As a Senior Consultant you will be assigned to (IT) compliance projects within the pharmaceutical, medical devices and life sciences industries. You will mainly work in laboratory, production and validation departments, so knowledge of and experience in these departments is an advantage. Knowledge of GxP and validation combined with a feeling for IT and compliance is a requirement. Your job is to contribute to improving or establishing the clients’ (IT) compliance by providing them with the best possible assistance with their issues. As a Senior Consultant you work on validation projects as project manager, high level consultancy projects in which you advice the client on the validation strategy for implementing IT solutions or interim management functions. In these roles you need besides in-depth knowledge about GxP compliance, good communication skills, persistence and an agile working attitude.
excellent in both Dutch and English language.
Please contact Joost Havers, Managing Consultant at +31 71 524 40 00 or by e-mail for additional information on job specifics.
As a result of the continuous growth of our company including our Regulatory Affairs Division we are looking for experienced professionals in Regulatory Affairs CMC. We offer a challenging environment working within our teams and for a wide range of clients in a role as (senior) consultant RA-CMC.
Being a consultant you will work on a wide range of projects that may cover the complete life cycle of a product from (early) development up to post approval maintenance. The projects range from small molecules to biologicals depending on your knowledge and experience. You can be assigned to customers looking for hands-on support and/or requiring advice on regulatory-CMC. The work may cover all aspects of RA-CMC ranging from development and advise on RA-CMC strategies, implementation of RA-CMC requirements in product development, support in scientific advice procedures, communication with health authorities and RA-CMC (Module 3, IMPD) technical writing. You may work at different sites which may be the office of our client, Xendo office or home based depending on the project requirements. Communication skills are key as you will communicate with many different functions within our client organisations like: RA, QA and QC functions, development, manufacturing but also with health authorities.
We are looking for highly motivated professionals who like to act in a dynamic environment and are able to adjust to different working environments. You are a self-starter and quick learner with excellent communication skills. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. Experience in CMC Regulatory Affairs within the (bio)pharmaceutical industry or health agencies is preferred. For the role of senior consultant several years in a (senior) CMC related position are required. Depending on your experience it is not an absolute requirement that the candidate will be based in the Netherlands. Fluency in English is required.
You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are also well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of regulatory changes on the products or portfolio of your customers.
We offer a responsible, independent position in a growing and ambitious organization, with the opportunity to develop yourself. We offer a competitive salary and secondary benefits. Xendo has a professional but informal working environment, an extended development program on hard and soft skills, a flexible and pleasant work atmosphere and over 200 international colleagues.
If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.
The Engineering & Facility Support Division is strengthening its engineering team with a Senior Project Manager Pharmaceutical Facilities. Are you an experienced engineering professional with a proven track record in project management and looking for challenge and growth, then this might be your chance! Xendo is a consultancy and project management organization in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector.
As a Senior Project Manager Pharmaceutical Facilities, you will be responsible for the executing of engineering tasks within multiple projects with a medium to long lead time (0.5 – 4 years). You will manage engineering projects both individually and within a multi-disciplinary team where you will have great influence and responsibilities. Your assignments will vary from conceptual or basic design of new laboratories or manufacturing facilities to consultancy and advice on maintenance management and improvement of maintenance planning as well as technical audits. You will be responsible for realizing all work, in accordance with the agreed budget, timescale, quality and performance criteria within the required procedures (health and safety, GMP, local and corporate standards). At times, you will work at the premises of our clients, but also from the Xendo office in Leiden. With your extended experience in facility engineering and project management, you would be considered a great and valuable asset to our company. You will report directly to the Managing Consultant Facility Engineering.
With your extended experience in facility engineering and project management, you would be considered a great and valuable asset to our company, reporting directly to the Managing Consultant Facility Engineering.
Solid Project Management (5-10 years) experience with specific experience within (bio) pharmaceutical (or related industries) and GMP.
Our projects span a wide range and in different phases in facility life science; an extended development program on hard and soft skills.
Within our Division Compliance & Validation we are recruiting for a Consultant Analytics /GMP who is ready to enter the world of consultancy. As a Consultant you will work in an ever-changing and challenging environment at our clients in the life sciences industries (e.g. (bio) pharmaceutical industry, medical devices, CMOs). You will act as the expert providing support in diverse development as well as GMP projects, e.g. analytical method development and/or validation, lab process improvements and tech transfer. You will also co-develop new R&D and GMP services for Xendo clients within the life science industry. Based on your affinity and experience with GMP (USA and EU) and your expertise in quality management you contribute to the quality (laboratory) management of our clients.
Usually, the work takes place at the clients’ site and entails working in a team of specialists in which related topics such as active substance, drug product, quality and regulatory aspects are discussed.
Currently our Analytics team is involved in the development of a broader range of services to support our customers in improving their processes. As a new team member you are challenged and invited to bring forward your expert ideas to contribute to these new or improved services.
For this role, we are looking for candidates with solid experience (4-6 years) in development (R&D), analytical methods for bioprocessing and/or QC testing of biologicals in the life science industry.
You have a bachelor or a master degree in Life Sciences (e.g. biology, (bio) chemistry, biotechnology, biomedical sciences or pharmacy). It is expected that you are able and willing to dig into the details yet keeping an eye on the overall goal of the project. You are result- and client oriented and have adequate interpersonal skills. You feel comfortable working with deadlines in an often changing environment and see it as a challenge to solve issues in a pragmatic and proactive way.
• a comprehensive development program on hard and soft skills.
If you are interested in this position, we encourage you to send your motivation and CV to us with the form below or by email to .

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