Manager Quality Assurance (5032)
On-site · St. Louis, Missouri, United States
Job Summary
Manager, Quality Assurance accountable for the performance and compliance of quality systems and operations within a regulated contract manufacturing environment. Provides final quality review and disposition decisions for raw materials, in-process materials, and finished goods to ensure regulatory and customer specifications. Serves as primary Quality leader for site with autonomy and decision-making authority, implementing cGMP requirements (21 CFR Parts 210/211), maintaining inspection readiness, and driving continuous improvement. Represents quality in communications with contract manufacturing customers, leading audits, questionnaires, technical requests, and documentation review; oversees deviations, investigations (OOS/OOT), CAPA, change control, batch record review, and product disposition; supports real-time manufacturing decisions related to deviations and non-conformances; ensures data integrity and quality system compliance across QA activities and customer interactions; collaborates with Manufacturing, Supply Chain, Engineering, and R&D to resolve quality issues and improve performance.
Required Qualifications
- Bachelor’s degree in Chemistry, Microbiology, Engineering, or related scientific discipline required
- Minimum 10 years of experience in a regulated industry (OTC drug, pharmaceutical, cosmetic, or similar)
- Minimum 5 years of progressive leadership experience in Quality Assurance or Quality Systems
- Demonstrated experience supporting FDA inspections and customer audits
- Experience in a contract manufacturing environment strongly preferred
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