Position: Test Lead/Manager/CSV Expert
Category: QA
English level: upper
Years of experience: 11

In different companies built test teams from scratch, introduced risk-based approach for testing, setup HP ALM as corporate test management tool together with JIRA/Confluence for requirements managements - this improved clarity of features development and testing in Agile/SCRUM (user story, acceptance criteria, DoD, retrospective) env., and based on that quality of the application improved; Created ISTQB Foundation certification training and conducted it for test engineers; Improved process of handling end-users requests. Coordinated test activities across different geographically distributed teams (USA, EU, Asia)
I have extended professional experience in IT software testing and validation of computerized systems used in clinical trials (14+) 
Certified in: ISTQB Test Manager, ISTQB Foundation, Scrum Master, QMS internal auditor (ISO 9001:2015 & ISO 19011:2018), member of IIBA.
Advanced IT QA testing background with professional experience in test methodologies, coordination test processes, creating test strategy, developing test schedules, developing test plans, reporting, E2E manual and regression testing, UAT,  implementing best practices with combined Business analysis experience (requirements elicitation, documentation, validation, negotiation) for different system including clinical data management systems, ERP, telecom, etc.
Build QA processes on the project from scratch including interview, hiring, performance review, career development. Developing, conducting trainings and mentoring team members.
UAT organizing with end-users, conducting demo and training sessions for group of people.
Able to interact professionally with a group of stakeholders, including senior executives, managers on all levels of organization and across companies  in English language (communication, verbal and written).
Experienced professional with GxP validation such as 21 CFR Part 11, GAMP5, Computerized System Validation (CSV) and practical line management experience in medical CRO/Pharma industry and software testing
No gaming, please;
Financial, ERP, clinical management systems, etc - are very welcome.