Director, Quality Control Operations

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: The Director of QC Operations leads the QC Operations team and is accountable for day-to-day Quality Control execution across Vaxcyte contract manufacturing and contract testing network. The role ensures the current business has the QC support it needs, that testing and release happen on time, and that Quality Control operates in a compliant, inspection-ready state through VAX-31 BLA and into commercial supply. As the executive function of Quality Control, the role provides leadership and oversight for implementation of the approved analytical control strategy and specifications at the contract manufacturing and contract testing organizations. Working closely with Analytical Development, Analytical Science and Technology, Stability, Quality Assurance, Regulatory Affairs, and the Analytical Technical Leads, this role is critical to timely, compliant, and uninterrupted release of Vaxcyte products. Essential Functions: • Day-to-Day QC Execution and Release • Leads the QC Operations team and is accountable for sample flow, testing schedules, and turnaround commitments across the contract testing network. • Provides leadership and oversight for implementation of the analytical control strategy and specifications at the contract manufacturing and contract testing organizations, as set through project team governance. • Oversight on reviews and approval of vendor documents supporting execution, including sampling plans, change controls, and test methods. • Ensures that QC operations deliver batch release through certificate of analysis generation and timely review and approval of analytical results. • Ensures on-time testing and release so that manufacturing and supply commitments are met. • Vendor Collaboration and Oversight • Acts as the main Global Analytical contact for QC routine operation with contract manufacturing and contract testing organizations. • Runs day-to-day operational oversight of external laboratories, including performance against agreed turnaround, quality, and compliance expectations. • Strengthens vendor collaboration through dedicated and focused working sessions and escalates commercial and contractual matters to Global Analytics and Technical Operations. • Quality Events, Investigations, and Data • Takes ownership of cross-component quality incidents related to analytics, including deviations, laboratory investigations, and out-of-specification and out-of-trend results, driving them to root-cause-based closure with corrective and preventive