Associate Director of External QA (Finished Goods)
Related skills
gmp regulatory capa cgmp ppq๐ 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.
๐ฏ 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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