Senior Manager, Quality Assurance, Drug Product

Vaxcyte Inc

San Carlos, United States
$166,000 – $193,000 py
On-site
Cgmp, ich guidelines, fda/ema regulations
Aseptic manufacturing (biologics) operations
Batch record review and disposition
The Senior Manager, Quality Assurance, Drug Product will play a critical role in ensuring the quality, safety, and compliance of commercial vaccine products

Job Summary

  • The Senior Manager, Quality Assurance, Drug Product will play a critical role in ensuring the quality, safety, and compliance of commercial vaccine products.
  • This leader will oversee QA activities related to manufacturing, batch disposition, deviations, and risk management, while actively participating in audits and continuous improvement initiatives.
  • The ideal candidate brings extensive QA experience in the biotech or pharmaceutical industry, strong leadership skills, and the ability to partner effectively across functions to support a culture of quality.

Matching Summary

The Senior Manager, Quality Assurance, Drug Product will play a critical role in ensuring the quality, safety, and compliance of commercial vaccine products.

Salary

$166,000 – $193,000

Skills & Requirements

Must-have

  • cGMP, ICH guidelines, FDA/EMA regulations
  • Aseptic manufacturing (biologics) operations
  • Batch record review and disposition
  • Deviation and product complaint investigations
  • Contract Manufacturing Organization oversight

Nice-to-have

  • Continuous improvement initiatives
  • Partner effectively across functions
  • Kindness-first, inclusive approach
  • Integrity, accountability, clarity

Key Requirements

  • 8+ years of QA experience in pharma/biotech
  • Experience in clinical and commercial parenteral drug product
  • Bachelor's degree in Chemistry, Biology, Pharmacy, or Engineering
  • Knowledge of Risk Management principles
  • Experience in annual product reports

Work Rights

Not specified

Tailored Resume

Cover Letter