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. Who You Are and What You Bring 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. Location San Francisco headquarters; 3 days/week in office. Compensation/Benefits 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 #J-18808-Ljbffr Scorpion Therapeutics