Senior Director, Quality Assurance

About the role

The Senior Director, Quality Assurance, provides strategic and hands-on QA leadership for our clinical-stage oral recombinant tablet vaccine programs and related GMP manufacturing, testing, and CMC activities. Reporting to the Chief Technology Officer, this leader is responsible for implementing and maintaining phase-appropriate quality systems that support compliant development, manufacture, testing, release, and supply of investigational products. Location: South San Francisco, CA - Onsite Role.

Responsibilities

• Lead implementation and day-to-day execution of GMP quality management systems supporting oral recombinant tablet vaccine development and manufacturing.
• Ensure compliance with applicable FDA, EMA, ICH, and other global GMP regulations, standards, internal policies, and procedures.
• Develop, implement, and monitor progress against strategic quality plan, quality objectives, projects, and goals in alignment with CMC and program priorities.
• Provide QA oversight of GMP manufacturing, analytical testing, stability, labeling, packaging, and release of clinical supplies for investigational oral tablet vaccine products.
• Review and approve Master Batch Records (MBRs), executed batch records, specifications, protocols, reports, change controls, deviations, investigations, CAPAs, and related documentation to ensure accuracy, completeness, data integrity, and cGMP compliance.
• Conducts and supports internal and external audits, GMP supplier qualification activities, including CDMOs, contract testing laboratories, raw material suppliers, and other contractors.
• Review and approve laboratory investigations (OOS/OOT/deviations) conducted by internal or external laboratories, ensuring thorough root cause analysis, robust corrective and preventative actions (CAPA), and aligned decision-making impacting product quality and disposition.
• Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, data integrity, and supply continuity.
• Ensure risk-based quality decisions are appropriately justified, documented, and aligned with internal procedures and regulatory expectations.
• Review executed batch records and supporting documentation for lot disposition, ensuring completeness, accuracy, and compliance with cGMP requirements, and confirming that all deviations, investigations, and quality events are appropriately resolved prior to batch release.
• Support regulatory submissions, health authority questions, inspection readiness, regulatory inspections, and