Responsibilities:

1. Lead batch record review and final disposition (approve, reject, hold) of finished product batches in compliance with regulatory requirements
2. Oversee and manage the batch release review team, ensuring timely, accurate, and compliant product release
3. Coordinate cross-functional activities with Production, QC Chemistry, QC Microbiology, QA Investigations, Supply Chain, and Regulatory teams
4. Perform QA functional review of deviations, exceptions, and OOS investigations, ensuring scientifically sound and compliant outcomes
5. Maintain batch disposition records and report on key quality metrics, including release cycle times and KPIs
6. Support regulatory inspections, customer audits, and internal audits as the subject matter expert for batch release processes
7. Review and approve documentation supporting Annual Product Quality Reviews (APQRs)
8. Provide leadership, coaching, and mentoring to QA staff involved in batch review and release activities

Requirements:

1. Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology, or related life science
2. 10+ years of progressive pharmaceutical QA experience in a CGMP-regulated manufacturing environment
3. 5+ years of leadership experience overseeing batch record review, batch disposition, and product release activities
4. Strong knowledge of CGMPs, GLPs, GDPs, and ALCOA+ data integrity principles
5. Experience supporting regulatory inspections and interacting with agencies such as FDA or other global health authorities
6. Proven experience reviewing deviations, investigations, and OOS results and familiarity with quality systems and document management systems (eQMS)
7. Experience in sterile or aseptic manufacturing environments preferred
8. SAP or similar ERP system experience preferred
9. Lean, Six Sigma, or quality certifications (ASQ, Greenbelt, etc.) are a plus