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Lab Compliance Manager

Vaxcyte
Location
San Carlos, California, United States
Posted
24 days ago
Department
Analytical
Salary
$153,000 - $178,000
What they actually want (must-haves)
  • Bachelor's degree in a life sciences discipline or equivalent experience
  • 8+ years of experience in a compliance, quality, analytical, or laboratory role within the biopharmaceutical or vaccine industry
  • Working knowledge of GMP and/or GLP principles
  • Experience authoring or contributing to controlled documents in a regulated environment
  • Familiarity with data integrity principles (ALCOA+) and Good Documentation Practices (GDP)
  • Experience executing or supporting equipment qualification activities in a regulated laboratory
Nice to have
  • Experience at a clinical-stage biopharmaceutical or vaccine company
  • Familiarity with FDA expectations for Phase I/II QC or analytical laboratory operations
  • Experience with electronic laboratory or quality systems such as Benchling or LIMS
  • Exposure to 21 CFR Part 11 compliance
  • Prior experience supporting internal audits or regulatory inspections
What the job really is

The Lab Compliance Manager at Vaxcyte will oversee compliance within the Analytical Development laboratories, ensuring adherence to GMP standards as the labs transition to a GMP-compliant environment. This role involves managing the Sample Management Specialist, authoring laboratory-specific SOPs, and implementing quality processes in collaboration with Quality Assurance. The manager will also maintain inspection readiness and support training for laboratory personnel.

Benefits
  • Competitive compensation package
  • Comprehensive benefits
  • Equity component
Things to weigh
  • Hybrid work arrangement requires a minimum of 3 days per week onsite
  • No specific salary details provided beyond the range
  • Role involves significant compliance responsibilities which may be challenging in a transitioning environment
Job score4/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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