Manager III, Quality Assurance (Product Release)
$173–$139,000 year
On-siteBethlehem, Pennsylvania, United States
Job Summary
Lead and develop a high-performing QA Product Release team responsible for batch review and release activities in a regulated pharmaceutical manufacturing environment. Plan, prioritize, and assign batch release work while partnering closely with Manufacturing, Planning, QC Laboratories, and other cross-functional teams. Ensure compliance with FDA regulations, including 21 CFR Parts 210, 211, and Part 11, GMP requirements, and company quality standards. Support regulatory authorities inspections and audits, ensuring inspection readiness and successful outcomes. Leverage systems such as SAP, LabWare/LIMS, and TrackWise to support quality and release processes. Drive operational excellence through coaching, conflict resolution, employee development, and strong cross-functional collaboration. Manage a team of 10-15 professionals.
Required Qualifications
- Bachelor's degree in a scientific discipline
- 10+ years of Quality Assurance experience within a pharmaceutical or biotech manufacturing environment
- Extensive experience with batch record review and product release
- Strong knowledge of FDA regulations (21 CFR 210, 211, and Part 11), GMPs, and pharmaceutical manufacturing processes
- Experience supporting FDA audits and regulatory inspections
- Proven leadership experience managing large teams and fostering accountability, collaboration, and continuous improvement
Desired Qualifications
- Master's degree or higher
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