Senior Manager, Quality Control

Senior Manager, Quality Control

The Senior Manager, Quality Control is responsible for leading QC laboratory operations, including full oversight of both analytical and microbiology laboratories, within a 503B outsourcing facility operating under 21 CFR Parts 210 and 211. This role ensures compliant, timely, and scientifically sound testing to support batch release, product quality, and regulatory expectations, with strong emphasis on data integrity, investigation quality, and inspection readiness.

cGMP QC Laboratory Oversight (Analytical & Microbiology)

• Lead daily operations of both analytical and microbiology QC laboratories
• Ensure timely testing and release of raw materials, in-process, finished products, and stability samples
• Manage lab capacity, staffing, and prioritization aligned with production demands
• Ensure compliance with 21 CFR 210/211 and ALCOA+ data integrity principles

Analytical Methods (Fit-for-Use in 503B)

• Oversee method verification, validation, and transfer
• Ensure methods are scientifically sound and appropriate for intended use
• Lead method troubleshooting, remediation, and lifecycle management

Microbiology Laboratory Oversight

• Provide full oversight of microbiology laboratory operations
• Ensure compliant execution of sterility (USP <71>) and endotoxin testing (USP <85>)
• Oversee bioburden and environmental monitoring programs
• Ensure microbiological practices support aseptic processing and contamination control strategy
• Partner with QA and Operations on EM trends, excursions, and risk assessments

Investigations & Technical Decision-Making

• Lead and approve OOS, OOT, and laboratory investigations
• Ensure investigations are scientifically sound and FDA-defensible
• Support batch impact assessments and disposition decisions

Contract Laboratory Oversight

• Manage external laboratory relationships and performance
• Support method transfer, investigations, and data review
• Ensure contract labs meet cGMP and data integrity expectations

Inspection Readiness

• Maintain QC in a constant state of inspection readiness
• Serve as QC representative during FDA and regulatory inspections
• Support and review 483 responses and regulatory documentation

Leadership & Culture

• Develop and lead QC analytical and microbiology teams
• Drive right-first-time execution and accountability
• Promote scientific rigor, data integrity, and quality ownership

Basic Qualifications

• Bachelor's degree in Chemistry, Microbiology, or related field (MS preferred)
• 8–12+ years in cGMP QC laboratories
• 3–5+ years leadership experience
• Experience supporting FDA inspections

Technical Expertise

• Strong knowledge of compendial methods and USP requirements
• Experience with HPLC, GC, and microbiological testing methods
• Understanding of OOS/OOT investigations and stability programs

Authority & Accountability

• Approval authority for QC data and investigations
• Authority to halt testing or product release based on quality risk

What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you'll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready for the challenge?

We're proud to be an equal opportunity employer. Diversity makes us stronger, and we're committed to creating an inclusive workplace where everyone feels welcome. Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.