Senior Manager, Quality Assurance

Responsibilities

• Serve as the QA lead for Drug Substance intermediates and custom raw material activities
• Provide oversight of deviations, investigations, risk assessments, change controls, and CAPAs at CMOs
• Conduct detailed reviews of batch records, disposition packages, and technology transfer documents
• Represent QA at internal and external cross-functional team meetings
• Develop, implement, and maintain QA procedures and policies for Drug Substance manufacturing
• Drive resolution of quality performance issues with contract manufacturers and escalate risks as needed
• Support technology transfer activities and process improvement projects

Requirements

• BS or BA degree with minimum 8 years of Quality Assurance experience
• In-depth knowledge of GMPs, FDA/EMA regulations, and ICH guidelines
• Strong knowledge of biologics manufacturing processes and Quality Systems
• Experience with good documentation practices, technical writing, and cGMP standards
• Proven ability to lead through influence in cross-functional teams
• Excellent verbal, written, and interpersonal communication skills

Preferred Qualifications

• Knowledge of both clinical and commercial product environments

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella.