Associate Director, Computer Validation Methods & Testing

Provide leadership to a customer segment of a Quality Assurance Unit focused on computer system validation to guide and advise project teams in planning and performing projects requiring validation of GxP systems.DUTIES & RESPONSIBILITIES- Use judgment to assess and guide projects on risk based approaches to validation plans, testing plans and overall project efforts
- Guide the development or enhancements of approaches, techniques and methods for Computer System Validation with focus on assuring high level of data integrity.
- Guide or perform the creation or enhancement of:
Standards, Templates, Procedures and Practices based on the combination of validation principles, software development best practices and CMM Maturity principles.
- Work with technology group members to improve testing techniques and use of test management tools
- Work with leaders of their customer segment to understand project and staffing demands and ensure QA is positioned to perform our roles within the project
- Help in the development or improvement of IT Good Validation Practices and complimentary Good IT / Project Management practices.
- Provide constructive feedback and trending information to validation projects and practioners that identifies areas for improvement of validation approaches and initiates continuous improvement efforts.
- Conduct periodic assessments and audits of internal and potentially technology vendors as assigned
- Maintain a comprehensive list of CSV projects and continuously plan resource allocation so that the QA group provides high level of customer service. Advise the CLS QA Unit team on staffing needs and issue for projects within their customer segment.
- Create and deliver training or educational information as assigned or per agreed goals or as assigned within the team.QUALIFICATIONS- 5-6 years in Pharmaceutical (Biotech) IT or Informatics and/or QA-Validation department
- 3-5 years experience performing and leading QA role in computer systems validation projects in GMP and Non-GMP regulated environments
- Thorough knowledge of GxPs,FDA & EMA and other international Regulations governing use of electronic records, electronic signatures and system validation including 21CFR Part 11, 58, 211, MHRA Annex 11 and associated guidance documents from US FDA, EMA and ICH.
- Computer Systems implementation & SDLC experience including 2+ full implementation cycles in project management at an FDA / EMEA regulated company of enterprise scale computer systems that required validation
- Experience designing and implementing validation plans or protocols, writing and implementing SOP's, Templates and other QA program infrastructure
- Good Hands on knowledge of Good Testing Practices including specific experience in developing and managing system test plans including writing/reviewing test cases and scripts and leveraging testing tools
- Strong cross functional view of Pharmaceutical company operations

Inter-Personal Skills:

- Excellent Communication, Time Mgmt and Team Building skills
- Ability to understand project objectives and guide validation planning, Test Planning and other key QA Validation activities
- Ability to manage via influence rather than control and work across departmental boundaries
- Detail oriented and willing to make personal contribution to the success of project assignments
- Ability to balance functional and corporate goals
- BS, MS in Computer Sciences, Engineering or related sciences or technical field