Senior Manager, Quality Control
Location: St. Louis, MO
Schedule: On-Site
Position Overview
We are seeking an experienced and strategic leader to oversee Quality Control operations across multiple manufacturing sites. This role is responsible for managing 24/7 in-process testing, raw material and finished product release, stability programs, and microbiological testing. The Senior Manager will drive compliance, operational excellence, and continuous improvement within a regulated pharmaceutical environment.
Key Responsibilities
Ensure timely testing and data release to meet service and compliance targets
Lead stability testing programs, ensuring 100% on-time execution of all scheduled intervals
Serve as the primary point of contact for analytical method transfers into QC
Manage and develop a cross-functional team of managers, supervisors, and analysts
Provide leadership on cGMP compliance and quality system enhancements
Act as Subject Matter Expert during internal and external audits
Implement Lean and Six Sigma tools to optimize QC processes
Standardize analytical methods to improve consistency and usability in lab settings
Collaborate with manufacturing and R&D on validations, campaigns, and special projects
Promote a strong safety culture and ensure compliance with EHS standards
Oversee compendial compliance and QC system administration
Qualifications
Education:
Bachelor's degree in Chemistry, Chemical Engineering, or a related scientific field (or equivalent experience)
Experience:
10+ years in pharmaceutical Quality Control or Quality Assurance
Proven leadership in managing teams and complex projects
In-depth knowledge of cGMP, GLP, and GXP regulations