Manager, Quality Assurance, External Manufacturing

Vaxcyte Inc

San Carlos, CA, United States
Base: $151,000 – $176,000 (sf bay area); bonus/equ...
Hybrid; san carlos, ca
Contract manufacturing organization oversight
Cgmp regulatory compliance knowledge
Batch record review and disposition
Vaxcyte Inc is seeking a Manager for Quality Assurance in External Manufacturing, responsible for overseeing quality activities at contract manufacturing organizations (CMOs) and ensuring compliance with cGMP standards. The ideal candidate will have extensive experience in pharmaceutical quality systems and a strong leadership presence

Job Summary

  • The role is responsible for overseeing quality activities at contract manufacturing organizations to ensure compliance with cGMP standards.
  • Candidates must have a minimum of 5 years of experience managing CMO quality within the pharmaceutical or biotechnology industry.
  • The position offers a competitive compensation package including comprehensive benefits and an equity component.

Matching Summary

Match Score: 85

Vaxcyte Inc is seeking a Manager for Quality Assurance in External Manufacturing, responsible for overseeing quality activities at contract manufacturing organizations (CMOs) and ensuring compliance with cGMP standards. The ideal candidate will have extensive experience in pharmaceutical quality systems and a strong leadership presence.

Salary

Base: $151,000 – $176,000 (SF Bay Area); Bonus/Equity: Equity component included; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Contract Manufacturing Organization oversight
  • cGMP regulatory compliance knowledge
  • Batch record review and disposition
  • Deviation and OOS investigation experience
  • Process Performance Qualification support
  • Quality Risk Management application

Nice-to-have

  • Experience with clinical and commercial products
  • Strong leadership and problem-solving skills
  • Ability to work in fast-paced environment
  • Cross-functional collaboration capabilities

Key Requirements

  • Bachelor's degree in chemistry, biology, pharmacy, engineering, or related field
  • Minimum 5 years of CMO quality management experience
  • Thorough knowledge of FDA/EMA regulations and ICH guidelines
  • In-depth understanding of biologics manufacturing operations

Work Rights

Not specified

Tailored Resume

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