Associate Director, Process Validation And Risk Management

Vaxcyte Inc

San Carlos, United States
$174,000 – $203,000 (sf bay area); not specified; ...
On-site
Process validation (ppq/cpv)
Msat, technical operations
Quality risk management (ich q9)
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases

Job Summary

  • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases.
  • The Associate Director, Process Validation and Risk Management will lead and facilitate commercial process validation and risk management activities across Vaxcyte’s end-to-end manufacturing processes.
  • This position will report to the Sr. Director of Process Validation within the Global MSAT organization and will collaborate on overall validation strategy, with primary responsibility for process validation execution and risk management frameworks supporting commercial manufacturing.

Matching Summary

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases.

Salary

$174,000 – $203,000 (SF Bay Area); Not specified; Not specified

Skills & Requirements

Must-have

  • Process validation (PPQ/CPV)
  • MSAT, technical operations
  • Quality risk management (ICH Q9)
  • Technology transfer and commercialization
  • Cross-functional team leadership

Nice-to-have

  • Innovative and entrepreneurial mindset
  • Creative approach to developing ideas
  • Kindness-first, inclusive approach

Key Requirements

  • 9+ years of relevant experience for Ph.D.
  • 11+ years for M.S./M.A.
  • 14+ years for B.S./B.A.
  • Biologics/vaccine manufacturing experience
  • Experience in quality risk management
  • Demonstrated leadership in matrixed teams

Work Rights

Not specified

Tailored Resume

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