Associate Director, Quality Assurance (GMP QC Lab Oversight)
$170,000–$200,000 year
On-site · Camarillo, California, United States
Job Summary
Associate Director, Quality Assurance (GMP QC Lab Oversight) provides strategic and operational QA oversight of GMP QC laboratory activities, ensuring cGMP compliance, instrument qualification, and timely review/approval of QC documentation (CoAs/CoTs) while driving investigations, deviations, and data integrity improvements. The role leads QA support for method transfer, validation, and technical transfer affecting QC operations, partners cross-functionally with QC, Manufacturing, Regulatory, and site leadership, and contributes to inspection readiness, Quality Management Review processes, and continuous improvement actions. Must have a bachelor’s degree in a scientific discipline with at least eight years’ GMP QC laboratory experience, hands-on QC experience, and strong knowledge of FDA cGMP and ICH guidelines, IQ/OQ/PQ, CAPAs, change controls, and data integrity. This on-site role requires Camarillo presence with possible travel up to 20%.
Required Qualifications
- Bachelor’s degree in a scientific discipline (or equivalent experience) with a minimum of 8 years of direct experience supporting GMP QC laboratory operations in a regulated pharmaceutical or biotechnology environment, including QA oversight
- Demonstrated experience in biologics/protein therapeutics, including manufacturing and testing of drug substance, drug product, and finished goods
- Demonstrated experience handling QC-related issues, records, and laboratory operations, including analytical documentation, deviations, and investigations, within a GMP environment; prior hands-on QC laboratory experience strongly preferred
- Experience reviewing and approving equipment and instrument qualification and validation documentation (e.g., IQ/OQ/PQ), with working knowledge of lifecycle management principles; experience applying risk-based approaches to computerized systems (GAMP 5) preferred
- Strong working knowledge of FDA cGMP regulations and ICH guidelines applicable to QC laboratory operations
- Experience leading and/or overseeing laboratory investigations, including OOS, OOT, deviations, CAPAs, change control, and data integrity events within a GMP environment
- Solid understanding of CoA/CoT generation and approval, and experience supporting batch disposition decisions in a GMP setting
- Demonstrated experience supporting internal audits, external audits, and regulatory inspections, including inspection readiness and response activities
- Strong written, verbal, and interpersonal communication skills, with the ability to effectively influence cross-functional teams
- Proven ability to exercise sound judgment, prioritize effectively, and operate successfully in a fast-paced, on-site GMP environment
- On-site presence in Camarillo is required to support daily GMP QC laboratory operations
- Up to 20% travel may be required to support audits, external laboratories, or business needs
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