Senior QC Operations & Global Analytics Lead (Hybrid)

Vaxcyte; Madison (NH); Vor Ort; USD 204.000 - 252.000; Vollzeit

Benefits dieser Stelle

Equity component

Zusammenfassung

Vaxcyte in Visp, Switzerland is seeking a Senior Manager Quality Control to serve as single point of contact for our Europe CDMO. You will implement analytical control strategies and ensure alignment with regulatory standards and GDP across testing and release.

You will oversee method validation, data management, and CoA reviews, ensuring on-time performance and effective CAPAs while collaborating with cross-functional teams in Analytics, Process Development, QA, Operations, and Regulatory.

Qualifikationen

• BS degree with minimum 8 years of relevant experience.
• Experience managing CDMOs and/or contract laboratories.
• Comprehensive knowledge of cGMP and multinational regulations.
• Excellent communication and stakeholder management skills.

Aufgaben

• Implement analytical control strategies at CDMOs and ensure regulatory compliance.
• Maintain robust QC systems for sampling, testing, documentation, and release.
• Ensure on-time QC testing at CDMOs/contract labs for materials and drug substance.
• Certify contracted labs have calibrated instrumentation per regulatory standards.
• Oversee method validation and transfer between contract labs.
• Manage QC data systems with GDP-compliant documentation and retention.
• Review analytical data, CoAs, and test reports for release and stability.
• Support investigations and CAPAs for OOS/OOT/OOE findings and incidents.
• Provide technical support for product inspections by Health Authorities.

Kenntnisse

Analytical thinking

Problem solving

Communication

Teamwork

Process improvement

Ausbildung

Bachelor of Science in biotech/pharma

Jobbeschreibung

Vaxcyte in Visp, Switzerland is seeking a Senior Manager Quality Control to serve as single point of contact for our Europe CDMO. You will implement analytical control strategies and ensure alignment with regulatory standards and GDP across testing and release.

You will oversee method validation, data management, and CoA reviews, ensuring on-time performance and effective CAPAs while collaborating with cross-functional teams in Analytics, Process Development, QA, Operations, and Regulatory.