Job Title: Associate Director, R&D Quality Assurance (Early-Stage Development)
Job Description: Element Staffing is recruiting for an Associate Director of R&D Quality Assurance for a pioneering, clinical-stage biopharmaceutical company located in Irvine, CA. This is a high-impact leadership role responsible for managing the quality oversight of early-stage contract drug product manufacturers, testing labs, and raw material suppliers. Reporting to the Director of QA, this individual will serve as the primary bridge between R&D and commercial readiness, ensuring that all preclinical through Phase II programs meet rigorous global GxP standards. The ideal candidate is a strategic problem-solver who thrives in a fast-paced, collaborative environment focused on bringing life-changing therapies to market.
Duties/Responsibilities/Qualifications:
- Vendor & CMO Oversight: Manage supplier quality for contract manufacturers, packagers, and testing labs; lead quality agreement negotiations and vendor calls.
- QMS Management: Develop, implement, and maintain Quality Management Systems (QMS) specifically tailored to support early development activities (Preclinical through Phase II).
- Technical Review & Approval: Review and approve investigations, deviations, and laboratory OOS (Out-of-Specification) results; oversee change controls for master manufacturing records and test methods.
- Disposition & Documentation: Review executed batch records and manage product disposition (CTM) for clinical trials. Review test method validation protocols, API specifications, and label requirements.
- Cross-Functional Leadership: Serve as the QA representative on development project teams, providing strategic input to Regulatory Affairs, CMC, Supply Chain, and Clinical Development.
- Compliance: Ensure strict adherence to global GxP regulations (GCP, GLP, GMP) and internal corporate policies.
- Audit Support: Support the writing and approval of regulatory submissions and SOPs; participate in supplier audits and risk mitigation strategies.
- Clinical Study Support: Provide QA oversight for blinded clinical studies (two/three-arm) and participate in CMC operational meetings.
Additional Information:
- Years of Experience: 12+ years in the Pharmaceutical Industry with at least 7 years specifically in Quality Assurance.
- Education: Bachelor’s Degree in a scientific or related field required.
- Shift/Travel: Hybrid schedule (3 days on-site in Irvine); travel required up to 15%.
- Requirements: Proven experience with root cause analysis, CAPA effectiveness, and early-phase clinical development. Strong knowledge of the drug development life cycle is essential.
- Compensation: $155,000 – $205,000 + Bonus, Equity, and Comprehensive Benefits.
- Location: Irvine, CA
