Computer Systems Validation & Software Quality Assurance Manager
Location: US, IL, Lake Forest
Employment type: Full-time
Required experience: Mid-Senior level
Required education: Bachelor's Degree
Industry: Management Consulting
Function: Consulting
Company profile: Praxis Life Sciences is a dynamic project management and consultancy practice servicing the life sciences industry. Praxis drives business improvement at pharmaceutical, medical device, and related companies through unique methods and knowledge applied by experienced, dedicated experts.Praxis is known in the industry for successfully navigating the demands and complexities of a changing regulatory marketplace. We specialize in helping businesses operate at maximum potential.
Description: Praxis Life Sciences is a dynamic life sciences consulting firm serving the pharmaceutical, biotech, and medical device industries. We have an immediate opening for a Computer Systems Validation (CSV) & Software Quality Assurance (SQA) Manager in our Lake Forest, IL office. The Manager will focus on leadership of CSV programs and projects, delivery of CSV documents, delivery of SQA training, and development and implementation of software quality assurance programs.The CSV Manager will play an integral role in expanding and seeding new CSV opportunities (programs, projects, training, and management of our validation website). This role will be responsible for building the relationship between Praxis and the client - helping to deliver a broad spectrum of CSV services and capabilities.The CSV manager will develop and deliver a variety of CSV & Software QA programs and projects. The manager will primarily be responsible for:Provide consulting services for companies seeking to implement or improve existing software quality assurance and validation programsProvide software quality and validation auditing servicesDesign training courses and develop training materials for both online and live courses.  Work with clients to tailor training to specific needs.Deliver training via webinar format, online instruction, and live instruction.Develop software quality assurance processes, procedures, and templatesDevelop Praxis’ CSV/SQA practice by contributing to the company web site, CSV newsletter, and CSV/SQA new business development efforts
Requirements: 6-10 years of comprehensive CSV/Software QA experience, including:Leadership of computer system validation programs and projects, including development of risk-based validation strategiesDevelopment and implementation of software quality assurance procedures, such as risk assessment, change control, vendor management, defect management, and configuration managementDelivery of training in software quality assurance and validation subjectsAuditing software quality and validation practicesExpertise in software quality assurance and validation regulations (e.g., US FDA, Eudralex), international guidelines (e.g., PIC/S, ICH, WHO), and industry standards (e.g., GAMP)6-10 years of delivery of computer system validation documents, including Validation Plans, Validation Reports, Test Protocols (IQ, OQ, PQ), Trace Matrices, in a broad range of situations, such as:Experience working with multiple FDA-regulated industries sectors. (e.g. pharmaceutical, medical device, biologics, clinical trial and/or software vendors for these industry sectors);Experience validating multiple categories of software. (e.g. laboratory, manufacturing control, clinical, medical device, inventory management, quality management and/or pharmacovigilance);Experience validating custom developed software, configured software applications and hosted systemsExcellent interpersonal, verbal and written communication skills, decision-making skills, business understanding, and strong organizational skillsAbility to work in an action-oriented, fast-paced and rapidly changing environmentAbility to lead virtual and global teamsAbility to travel as needed for the positionPraxis Life Sciences is an equal opportunity employerQualifies candidates must be legally eligible to work for any employer in the United States.
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