Associate Director of External QA (Finished Goods)

Added
1 hour ago
Type
Contract
Salary
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Related skills

gmp regulatory capa cgmp ppq

๐Ÿ“‹ Description

  • Leads and participates in cross-functional production teams, internal and external.
  • Drives product teams to ensure Adverum Quality, Manufacturing, and milestones are met.
  • Drives PPQ and comparability production campaigns.
  • Ensures quality requirements are planned, completed, and documented in the Quality system.
  • Leads investigations and oversees CAPA implementation.
  • Partners with leadership to integrate with corporate systems and ensure GMP compliance.

๐ŸŽฏ Requirements

  • Bachelor's degree in biological sciences or related field.
  • 13+ years in pharma with Manufacturing, Quality Control, and QA experience.
  • Expert knowledge of multi-regional regulatory requirements for Quality systems.
  • Experience with cold and ultra-cold chain is preferred.
  • Ability to read, analyze, and interpret standards and regulations.
  • Strong organizational, management, and cross-functional leadership skills.
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