Associate Director, Computer & Lab Systems QA & Validation

Provide leadership in a Quality Unit focused on computer system validation for performing QA roles in the development, modification and implementation of GxP related computer systems across all GxP groups within MPIDUTIES & RESPONSIBILITIES- 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 IT and Medical Informatics to adopt and Good Validation Practices and develop complimentary Good IT / Project Management practices with their organizations.
- Provide constructive feedback and trending information to validation projects and practioners that identifies areas for improvement of validation approaches and initiates continuous improvement efforts.QUALIFICATIONSMinimum Qualifications
- 7 years in Pharmaceutical (Biotech)IT or Informatics and QA-Validation department
- 5 years experience performing and leading 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 programs, 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 conceive, design and implement change
- Ability to manage via influence rather than control and work across departmental boundaries
- Detail oriented and willing to make personal contribution
- Ability to balance functional and corporate goals