Senior Manager, Quality Control
Job in
Wichita, Sedgwick County, Kansas, 67232, USA
Listed on 2026-07-08
Listing for:
Fagron Sterile Services US (FSS)
Full Time
position Listed on 2026-07-08
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Company Overview
Since 1990, we have grown into a global leader in personalized medicine. Today, our more than 5,000 energetic employees are based in 80 locations worldwide, supporting over 200,000 customers.
About the JobThe 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.
Responsibilities- 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) and endotoxin testing (USP)
- 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
- 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
- Develop and lead QC analytical and microbiology teams
- Drive right-first-time execution and accountability
- Promote scientific rigor, data integrity, and quality ownership
- Bachelors degree in Chemistry Microbiology, or related field (MS preferred)
- 812+ years in cGMP QC laboratories
- 35+
Position Requirements
10+ Years
work experience
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