Director, Quality Control Operations

The role

The Director of QC Operations leads the QC Operations team and manages day-to-day Quality Control execution across contract manufacturing and testing networks. This role ensures timely testing and release while maintaining a compliant, inspection-ready state through commercial supply.

What you will do

• Leads the QC Operations team and is accountable for sample flow, testing schedules, and turnaround commitments.
• Provides leadership and oversight for implementation of the analytical control strategy and specifications at contract organizations.
• Oversees reviews and approval of vendor documents including sampling plans, change controls, and test methods.
• Ensures QC operations deliver batch release through certificate of analysis generation and timely review of analytical results.
• Acts as the main Global Analytical contact for QC routine operation with contract organizations.
• Runs day-to-day operational oversight of external laboratories.
• Takes ownership of cross-component quality incidents including deviations, laboratory investigations, and out-of-specification results.
• Authors and maintains QC policies, standard operating procedures, work instructions, and templates.
• Supports regulatory inspections, pre-approval inspection readiness, and customer and partner audits.
• Leads, develops, and coaches the QC Operations team across sites and time zones.

Required qualifications

• 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.
• Strong organizational, management, teamwork, and interpersonal skills, and professionalism.
• Relentless focus and passion around process improvements, efficiency, and automation.

Nice to have

• Vaccine or conjugate vaccine experience preferred

Benefits

• Comprehensive benefits
• Equity component

Before you apply

• This role is not eligible for relocation assistance.

About the company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.