Associate Director Quality Control Jobs in California

The Associate Director, Technical Operations Quality Control, leads QC execution and program-level strategy across assigned programs and external testing partners (e.g., CDMOs/CTLs) from Phase 1 through commercialization. This role translates QC strategy into integrated execution plans and ensures timely, compliant delivery of QC activities, including release and stability testing, method lifecycle management, reference standard and critical reagent oversight, and vendor performance management.

The Associate Director partners cross-functionally with Quality, Technical Operations, Manufacturing, Regulatory, Analytical Development, and Stability to deliver CMC milestones, maintain inspection readiness, and support global regulatory submissions. This individual provides technical and operational leadership across multiple programs, may manage or mentor QC colleagues, and drives continuous improvement in QC processes, systems, and external network performance.

This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.

• Translate and implement QC strategy for assigned programs and external testing networks in alignment with QC, Quality, and Technical Operations objectives.
• Lead QC activities across the product lifecycle (Phase 1 through commercial) for multiple programs, ensuring phase-appropriate control strategies and timely execution of analytical deliverables.
• Lead development and refinement of QC strategies, including methods, specifications, testing approaches, and external laboratory execution models, in collaboration with Analytical Development and QC leadership.
• Drive consistent execution and harmonization of QC methods, specifications, practices, and documentation across programs and external partners.
• Identify, assess, and escalate risks to QC performance, supply continuity, regulatory commitments, and compliance; develop and drive mitigation plans with cross-functional stakeholders.
• Represent QC as a program lead on CMC teams, program teams, and analytical sub-teams, ensuring alignment of QC deliverables, timelines, and readiness for key CMC milestones.
• Provide leadership, coaching, and technical guidance to QC colleagues and external partners; may directly manage employees or consultants supporting QC execution.
• Oversee QC operations to ensure timely, compliant testing for clinical and commercial programs, including release and stability testing performed internally and at CDMOs/CTLs.
• Oversee review of analytical data, batch records, CoAs, and supporting GMP documentation; ensure issues are appropriately evaluated, documented, and escalated.
• Lead or oversee QC GMP processes, including deviations, OOS/OOT, change controls, investigations, CAPAs, and related impact assessments in collaboration with QA.
• Manage CTL/CDMO performance and routine operational interactions, including governance meetings, issue resolution, metrics review, and accountability for agreed deliverables.
• Lead method lifecycle activities, including qualification, transfer, validation, implementation, optimization, and ongoing performance monitoring across internal and external laboratories.
• Partner with Analytical Development to support method development, comparability or bridging studies, assay trending, and lifecycle management of release and stability specifications for drug substance and drug product.
• Oversee reference standards, assay controls, and critical reagents used in QC, ensuring appropriate characterization, qualification, availability, and fit-for-purpose use across internal and external labs.
• Support QC contributions to regulatory filings and health authority responses, including method validation, specification justification, stability-related content, and inspection readiness materials.
• Serve as a QC subject matter expert during audits, technical visits, due diligence activities, and health authority inspections.
• Drive continuous improvement initiatives across QC processes, systems, vendor oversight, data review practices, and external network performance.

• BA/BS with 12+ years experience, MA/MS/MBA with 10+ years experience, or PhD with 8+ years experience in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering, or a related discipline is preferred.
• Technical expertise in a wide range of analytical methods for release and stability testing of biologics, including monoclonal antibodies and/or recombinant protein products.
• Strong scientific background in Quality Control and/or assay development in the biotechnology or pharmaceutical industry, with strong knowledge of cGMP, ICH, FDA, and EMA expectations.
• Demonstrated experience with analytical test method optimization, qualification, validation, transfer, implementation, and lifecycle management.
• Experience overseeing external partners, including CDMOs and CTLs, and driving performance, issue resolution, and compliance in an outsourced operating model.
• Experience supporting CMC regulatory submissions, health authority responses, audit readiness, and inspection readiness activities.
• Strong written and verbal communication skills, with demonstrated ability to lead cross-functional teams, influence stakeholders, and communicate complex technical information clearly.
• Demonstrated ability to assess risk, prioritize work across multiple programs, and drive timely execution in a fast-paced, matrixed environment.