Lead cross-functional production teams, internal and external.
Drive QA oversight with external partners to meet milestones.
Drive PPQ and comparability campaigns; ensure quality documentation.
Lead investigations and implement CAPA in quality systems.
Provide strategic leadership for product supply integrity and GMP compliance.
Collaborate with leadership to align with corporate systems and readiness for commercial stage.

🎯 Requirements

Bachelor's degree in biological sciences or related field.
13+ years in pharma with Manufacturing, QC, QA; cell culture/viral vector exp preferred.
Expert knowledge of multi-regional regulatory requirements for Quality systems.
Experience with ICH, US and EU regulatory requirements and audits.
Ability to write quality standards, SOPs, and mentor staff; strong communication.
Willingness to travel occasionally; proven cross-functional leadership.

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