Associate Director, Quality Control

Associate Director, Technical Operations Quality Control What You’ll Do

• Translate and implement QC strategy for assigned programs and external testing networks (CDMOs/CTLs) aligned with QC/Quality/Technical Operations objectives.
• Lead QC activities across the product lifecycle (Phase 1 through commercial) for multiple programs, ensuring phase-appropriate control strategies and timely analytical deliverables.
• Develop/refine QC strategies (methods, specifications, testing approaches, and external execution models) with Analytical Development and QC leadership.
• Drive harmonization of QC methods/specifications/practices/documentation across programs and partners.
• Identify/escalate QC performance, supply, regulatory, and compliance risks; develop mitigation plans.
• Represent QC on CMC/program teams; align QC deliverables and readiness for key CMC milestones.
• Provide leadership/coaching; may manage/mentor QC colleagues and external partners.
• Oversee QC operations for timely, compliant release/stability testing (internal and outsourced).
• Oversee GMP documentation review (analytical data, batch records, CoAs); manage deviations, OOS/OOT, change controls, investigations, CAPAs with QA.
• Manage CTL/CDMO performance (governance, metrics, issue resolution).
• Oversee method lifecycle (qualification/transfer/validation/implementation/optimization/ongoing monitoring).
• Oversee reference standards and critical QC reagents.
• Support regulatory filings/health authority responses and serve as QC SME for audits/technical visits.
• Drive continuous improvement across QC processes and external network performance.

• BA/BS (12+ yrs), MA/MS/MBA (10+ yrs), or PhD (8+ yrs) in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering, or related field (preferred).
• Technical expertise in analytical methods for biologics release/stability (e.g., mAbs, recombinant proteins).
• Strong knowledge of cGMP, ICH, FDA, and EMA; QC and/or assay development background.
• Experience with analytical method optimization, qualification, validation, transfer, implementation, and lifecycle management.
• Experience overseeing external partners (CDMOs/CTLs) in an outsourced model.
• Experience supporting CMC regulatory submissions, health authority responses, audit/inspection readiness.
• Strong communication; ability to assess risk, prioritize across programs, and execute in a matrixed environment.

San Francisco headquarters; 3 days/week in office.

• Expected salary range: $162,500–$227,500/year; includes compensation, bonus and equity plus benefits
• health/welfare plans
• non-accrual PTO
• holiday shutdown
• commuter benefits
• 401K match
• lunch in office