Senior Manager, Quality Control Operations, Global Analytics

Summary:

As Vaxcyte’s products progress towards late stage and commercialization, we are looking for people with experience in Quality Control for late stage or commercial products to strengthen our global Quality Control team.

Within that Quality Control Organization, we are seeking a Senior Manager Quality Control acting as single point of contact for our CDMO in Europe. The Senior Manager QC will represent the executive function of QC ensuring analytical strategies are implemented at our CDMO and/or external testing lab to ensure the quality, accuracy, and compliance of testing and analytical services. Working closely with the analytical technical lead and other functions within Analytics, Process Development, Quality Assurance, Operations, and Regulatory functions, this role is accountable that testing and release is performed at our CDMO in a timely and compliant manner to ensure secure and uninterrupted supply of Vaxcyte’s innovative therapies.

Essential Functions:

• Implement the analytical control strategy for our programs at our CDMO/contract labs and ensure they are aligned with the CDMO's goals and objectives as well as comply with relevant regulations and industry standards.
• Implement, and maintain robust quality control systems that encompass sampling, testing, documentation, and release procedures.
• Ensure on-time performance for QC testing at our CDMO’s or contract laboratories related to raw materials, intermediates, and drug substance
• Ensure that contracted QC laboratories are equipped with appropriate instrumentation and equipment, maintained according to regulatory requirements, and calibrated regularly to ensure accuracy and reliability of test results.
• In partnership with analytical technical lead and analytical science and technology as well as the contract laboratories, oversee method validation and transfer activities between contract laboratories.
• Assure that appropriate systems for data management, including secure storage, retrieval, and retention of QC data and documentation are in place. Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
• Review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both release and stability testing.
• Support investigations and deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement corrective and preventive actions (CAPAs).
• Provide technical support for product related inspections by Health Authorities.
• Writing, review and approval of documents related to Quality Control to ensure compliance with applicable regulatory and industry standards.

Requirements:

• Bachelor of Science with minimum 8 years of relevant experience in biotechnology/pharmaceutical industry.
• Experience in Pneumococcal vaccines is a plus.
• Excellent experience in managing CDMOs and/or contract laboratories.
• Comprehensive knowledge in cGMP and experience in multi-national regulations.
• Excellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
• Strong teamwork and interpersonal skills.
• Relentless focus and passion around process improvements (efficiency and automation).