Endo · 3 months ago
Sr Manager - Quality Testing
St. Louis, MO (Pharma) - USA032
Full-time
Onsite
Senior Level, Lead/Staff
15+ years expEndo is dedicated to developing and delivering life-enhancing products through focused execution. The Sr Manager - Quality Testing will manage key product and stability testing groups, oversee compliance activities, and provide leadership regarding cGMP compliance for the Generics Business.
Pharmaceuticals
Responsibilities
Ensure key turnaround timelines for customer service and compliance requirements are achieved
Manage stability testing to achieve 100% on-time analysis for all stability protocol testing intervals
Serve as the primary liaison for method transfers into the QC organization
Accomplishes results through subordinate managers, supervisors, exempt specialist employees and non-exempt employees
Provide overall leadership to QC groups regarding cGMP compliance improvement and enhancement
Serve as the Subject Matter Expert during compliance audits
Study and improve various Quality processes through increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation
Drive Quality consistency through revising or combining various analytical methods to ensure adequacy and quality with special emphasis on actual utility of methods under normal QC conditions
Work with all Quality managers, supervisors and analysts to address any laboratory concerns regarding safety, methods, procedures, or operation
Act as a liaison between the labs and manufacturing/ R&D in implementing special projects, production campaigns, or assist with validations or method transfers
Works with various reports and QC groups to ensure compliance to Environmental Health and Safety and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in our laboratories
Ensure compliance with and oversee compendia affairs for SpecGx
Qualification
Required
BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies
Minimum of 15 years related experience in Quality with 10 years management experience required
Proven personnel and project management history
Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements
Preferred
Excellent communication and leadership skills
Ability to work in and promote a team environment
Working knowledge of Six Sigma and/or Lean manufacturing tools
Complete understanding and application of principles, concepts, practices, and standards within discipline
Ability to lead and influence people
Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations
Knowledge of US and International pharmaceutical manufacturing regulations
Company
Endo
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
Founded in 1997Malvern, , US
1001-5000 employeesFunding
Current Stage
Late StageLeadership Team
Blaise Coleman
President and Chief Executive Officer
Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
Recent News
2025-09-23
2025-09-22
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