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Vaxcyte is a clinical-stage vaccine innovation company developing high-fidelity vaccines to protect against bacterial diseases including invasive pneumococcal disease, Group A Strep, and Shigella. As the company progresses toward late-stage development and commercialization, we are seeking a Senior Manager of Quality Control Operations to serve as the single point of contact and executive representative for our Contract Development and Manufacturing Organization (CDMO) in Europe.
In this role, you will oversee all quality control functions at our European CDMO and external testing laboratories, ensuring that analytical strategies are implemented correctly, testing is performed on schedule, and all activities comply with regulatory requirements. You will work closely with the analytical technical lead, Process Development, Quality Assurance, Operations, and Regulatory teams to maintain secure and uninterrupted supply of our innovative therapies.
Key responsibilities include:
- Implementing and maintaining the analytical control strategy across CDMO and contract laboratories, aligned with business objectives and regulatory standards
- Establishing and maintaining robust QC systems covering sampling, testing, documentation, and release procedures
- Ensuring on-time QC testing performance for raw materials, intermediates, and drug substance
- Overseeing equipment maintenance, calibration, and regulatory compliance at contracted laboratories
- Managing method validation and transfer activities between contract laboratories in partnership with analytical teams
- Ensuring secure data management, documentation, and compliance with Good Documentation Practices (GDP)
- Reviewing and approving analytical data, test reports, and certificates of analysis (CoAs) for accuracy and compliance
- Supporting investigations of deviations, out-of-specification results, laboratory incidents, and customer complaints; implementing corrective and preventive actions (CAPAs)
- Providing technical support during Health Authority inspections
- Writing, reviewing, and approving QC-related documents for regulatory compliance
This role reports to the Director of QC Business Operations and requires a hybrid work arrangement with a minimum of 3 days per week onsite in Visp.
Requirements:
- Bachelor of Science degree with minimum 8 years of relevant experience in biotechnology or pharmaceutical industry
- Excellent experience managing CDMOs and/or contract laboratories
- Comprehensive knowledge of cGMP and multi-national regulatory requirements
- Strong communication, negotiation, and relationship-building skills with ability to collaborate effectively across internal and external stakeholders
- Strong analytical and problem-solving abilities with focus on data-driven decision-making and continuous improvement
- Strong teamwork and interpersonal skills
- Relentless focus on process improvements, efficiency, and automation
- Experience with pneumococcal vaccines is a plus
