Job Description

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

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