Associate Director, Quality Control Operations, Global Analytics

Responsibilities

• Implement and maintain analytical strategies for process-related, release, and stability testing at CDMOs and contract laboratories.
• Oversee the implementation of robust quality control systems, including sampling, testing, documentation, and release procedures.
• Ensure on-time performance for QC testing related to raw materials, intermediates, and drug substances.
• Manage method validation and transfer activities in partnership with analytical technical leads and contract laboratories.
• Review and approve analytical data, test reports, and certificates of analysis (CoAs) to ensure accuracy and compliance.
• Lead investigations into deviations, out-of-specification (OOS), out-of-trend (OOT), and out-of-expectation (OOE) results.
• Implement corrective and preventive actions (CAPAs) in collaboration with internal stakeholders and external partners.
• Provide technical support for regulatory documents and inspections by Health Authorities.

Requirements

• Bachelor of Science degree.
• 10+ years of relevant experience in the biotechnology or pharmaceutical industry, specifically within Quality Control.
• Extensive experience managing CDMOs and/or contract laboratories.
• Comprehensive knowledge of cGMP and multi-national regulatory requirements.
• Strong analytical and problem-solving skills with a focus on data-driven decision-making.
• Excellent communication, negotiation, and relationship-building skills.

Preferred Qualifications

• Experience specifically related to Pneumococcal vaccines.
• Proficiency with digital tools for data management and document review workflows.
• A relentless focus on process improvements, including efficiency and automation.

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are guided by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.