Lead cross-functional production teams, internal and external.
Drive PPQ and comparability campaigns; ensure QMS documentation.
Lead investigations and implement CAPA.
Provide strategic leadership for product supply integrity and global GMP compliance.
Collaborate with leadership to prep for commercial stage and system integrations.
Represent Quality in forums and drive continuous quality improvements.

🎯 Requirements

Bachelor’s degree in biological sciences or related field.
13+ years in pharma with Manufacturing, QC, QA roles.
Cell culture and viral vector platforms experience.
Expert knowledge of multi-regional regulatory requirements for Quality systems.
Experience with ICH, US and EU regulatory requirements.
Experience presenting and responding to regulatory agency audits.

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