Quality Manager GxP
Position: GxP Qualilty Assurance Manager
Location: Foster City, CA
Type: Contract on W2
MUST HAVE Pharma/Biotech FDA compliant software quality and validation experience.
Responsible for Quality Assurance (QA) oversight of GxP software quality and validation, which includes but is not limited to, Infrastructure QA approvals of Specification, IQ, OQ, System specific procedures related to IT-owned systems and the enforcement of applicable standard operating procedures.
- 8-12 years experience in validation/quality assurance oversight
- Extensive knowledge of FDA regulations, 21CFRPartII, GAMP5, GLP, GMP and/or GCP compliance
- Experience managing and overseeing the software validation and infrastructure qualification process
- Proficient in authoring, reviewing and approving SDLC documentation in compliance with FDA regulations including validation protocols. (eg. IQ, OQ, PQ)
- Experience with FDA audits, CAPA, change management and quality assurance processes.
- Ability to collaborate and work well with others
- Ability to manage multiple tasks.