Build and maintain relationships with external CMOs and internal stakeholders
Provide hands-on technical oversight of manufacturing at CMOs, ensuring compliance
Own and lead batch records review and approval, ensuring cGMP compliance
Act as technical authority for batch disposition readiness and issue resolution
Ensure prompt execution of manufacturing and supply plans with risk mitigation
Drive investigations of deviations, OOS/OOT, and product complaints with RCA/CAPA

🎯 Requirements

BS/BA in Life Sciences, Engineering desirable
10+ years in pharma manufacturing/regulatory operations
Strong cGMP manufacturing experience with shop-floor exposure
Batch records review expertise; understanding critical parameters and data integrity
ERP/MRP experience; BOMs and master data
Travel ~25% required

🎁 Benefits

Equal opportunity employer
Hybrid work options
GDPR policy available prior to applying

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