Review and approve GMP documents per QMS and health agency regs.
Collaborate with Manufacturing/Supply Chain to resolve deviations, CAPAs, and batch releases.
Participate in GMP service provider audits per QMS and regulatory requirements.
Conduct QMS reviews with executives to assess effectiveness.
Create and revise SOPs, ensuring periodic review requirements are met.
Upgrade Vendor Management Program with QA procedures.

🎯 Requirements

Bachelor's degree in a scientific discipline or biotech.
10+ years pharma experience with 5+ in QA (or MS/PhD).
Strong knowledge of ICH, USP, 21 CFR parts, EMA incl. vendor mgmt.
GMP expertise for development, clinical supplies, and commercial DP/DS.
Hands-on biologics QA; launch experience desired.
Vendor Management (audits, quality agreements) and defending program during inspections.

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