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 actions.
• Ensures that QC Operations takes ownership or provide support on 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 actions.
• Owns trending of analytical data related to release and escalates emerging risk to the Head of Quality Control and the relevant Analytical Technical Lead.
• Ensures data integrity principles are applied in all QC activities in compliance with Vaxcyte policies, guidelines, and procedures.
• Controlled Documentation and Compliance
• Authors and maintains the QC policies, standard operating procedures, work instructions, and templates that describe how QC operates today, and keeps them current as the process changes.
• Ensures QC activities comply with cGMP, global regulatory requirements, and internal standards.
• Implements the QC framework and governance developed for commercial readiness into routine QC practice.
• Audit and Inspection Support
• Supports regulatory inspections, pre-approval inspection readiness, and customer and partner audits with QC due diligence, documentation, and subject matter expertise.
• Ensures QC records, results, and investigations are complete, retrievable, and defensible.
• Team Leadership and Capability
• Takes ownership of QC operations training curricula and status of training.
• Leads, develops, and coaches the QC Operations team across sites and time zones, setting clear priorities and performance expectations.
• Plans QC Operations resources in alignment with manufacturing and testing schedules so that analytical deliverables and testing are carried out to quality standards.
• Builds a culture of accountability, learning, and collaboration, and partners with Quality Assurance as one quality unit.

Requirements: 

• Bachelor of Science with 10+ years of relevant experience in the biotechnology or pharmaceutical industry.
• Direct leadership of a GMP quality control function, including line management of a QC team.
• Experience managing and overseeing contract laboratories and contract manufacturing organizations, including performance monitoring.
• Comprehensive knowledge of cGMPs and multi-national regulations.
• Demonstrated ownership of deviations, out-of-specification investigations, and corrective and preventive actions in a GMP laboratory setting.
• Experience supporting regulatory inspections and partner audits from a quality control standpoint.
• Experience authoring GMP controlled documents, including standard operating procedures, work instructions, and templates.
• Excellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong organizational, management, teamwork, and interpersonal skills, and professionalism required.
• Relentless focus and passion around process improvements, efficiency, and automation.
• Vaccine or conjugate vaccine experience preferred.