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Senior Manager, Quality Control

Fagron Sterile Services

Wichita, KS

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JOB DETAILS
SKILLS
Analysis Skills, Asepsis, Chemistry, Code of Federal Regulations, Current Good Manufacturing Practice (cGMP), Data Quality, Environmental Monitoring, Environmental Work, Establish Priorities, FDA Requirements, Genomics, Healthcare, Identify Issues, Laboratory, Laboratory Analysis, Laboratory Management, Laboratory Operations, Leadership, Maintain Compliance, Medicine, Microbiology, Operational Audit, Operations, Outsourcing, Public/Media/Press/Analyst Relations, QA Partner Testing Software, Quality Control, Quality Management, Regulations, Risk Analysis, Testing, Time Management, Trend Analysis, Validation Testing
LOCATION
Wichita, KS
POSTED
8 days ago
This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13596658 ## Who We Are Since 1990, weve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacificand are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better. Were passionate, science-driven, and always looking for new ways to improve lives. ## About the Job [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.]{contrast="auto"} **[cGMP QC Laboratory Oversight (Analytical & Microbiology)]{contrast="auto"}** - [Lead daily operations of both analytical and microbiology QC laboratories]{contrast="auto"} - [Ensure timely testing and release of raw materials, in-process, finished products, and stability samples]{contrast="auto"} - [Manage lab capacity, staffing, and prioritization aligned with production demands]{contrast="auto"} - [Ensure compliance with 21 CFR 210/211 and ALCOA+ data integrity principles]{contrast="auto"} **[Analytical Methods (Fit-for-Use in 503B)]{contrast="auto"}** - [Oversee method verification, validation, and transfer]{contrast="auto"} - [Ensure methods are scientifically sound and appropriate for intended use]{contrast="auto"} - [Lead method troubleshooting, remediation, and lifecycle management]{contrast="auto"} **[Microbiology Laboratory Oversight]{contrast="auto"}** - [Provide full oversight of microbiology laboratory operations]{contrast="auto"} - [Ensure compliant execution of sterility (USP \<71\>) and endotoxin testing (USP \<85\>)]{contrast="auto"} - [Oversee bioburden and environmental monitoring programs]{contrast="auto"} - [Ensure microbiological practices support aseptic processing and contamination control strategy]{contrast="auto"} - [Partner with QA and Operations on EM trends, excursions, and risk assessments]{contrast="auto"} **[Investigations & Technical Decision-Making]{contrast="auto"}** - [Lead and approve OOS, OOT, and laboratory investigations]{contrast="auto"} - [Ensure investigations are scientifically sound and FDA-defensible]{contrast="auto"} - [Support batch impact assessments and disposition decisions]{contrast="auto"} **[Contract Laboratory Oversight]{contrast="auto"}** - [Manage external laboratory relationships and performance]{contrast="auto"} - [Support method transfer, investigations, and data review]{contrast="auto"} - [Ensure contract labs meet cGMP and data integrity expectations]{contrast="auto"} **[Inspection Readiness]{contrast="auto"}** - [Maintain QC in a constant state of inspection readiness]{contrast="auto"} - [Serve as QC representative during FDA and regulatory inspections]{contrast="auto"} - [Support and review 483 responses and regulatory documentation]{contrast="auto"} **[Leadership & Culture]{contrast="auto"}** - [Develop and lead QC analytical and microbiology teams]{contrast="auto"} - [Drive right-first-time execution and accountability]{contrast="auto"} - [Promote scientific rigor, data integrity, and quality ownership]{contrast="auto"} ## Basic Qualifications [Bachelors degree in Chemistry Microbiology, or related field (MS preferred)]{contrast="auto"}[]{ccp-props="{}"} [812+ years in cGMP QC laboratories]{contrast="auto"}[]{ccp-props="{}"} [35+ ]{contrast="auto"}

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Fagron Sterile Services

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