Job Summary
A healthcare company is in need of a Remote CSV Quality Management Systems Associate Director in Princeton.
Candidates will be responsible for the following:
- Providing quality oversight and compliance support to implement and validate electronic systems
- Developing or reviewing protocol, plans, scripts, reports etc
- Providing QA oversight during risk, Part 11 and Annex 11 and regulatory assessments
Skills and Requirements Include:
- Travel 10-15% domestically/internationally
- 3-5 years of supervisory experience within CSV involving validation activities and system administration
- Bachelor's Degree in a technical discipline or related field
- Minimum of 10 + years of experience in an FDA regulated environment
- Strong knowledge of regulatory compliance pertaining to software validation in QA/IT infrastructure
- Demonstrated understanding of 21 CFR Part 11, Annex 11, FDA Quality System Regulation
