Quality Control Manager
$112,605–$168,907 year
On-siteBogart, Georgia, United States
Job Summary
Lead QC operations to ensure laboratory activities are compliant, efficient, and safe while applying testing, Lean, and safety standards. Manage QC laboratory teams supporting in-process testing, microbiological site support, and CLO testing activities. Oversee laboratory scheduling, performance, and validation of test methods and instruments for commercial release. Direct the environmental monitoring program and drive analytical method transfers to support the QC transgenic roadmap. Lead recruitment, retention, and development of QC staff while overseeing training strategies and investigations. Ensure inspection readiness by representing QC during audits and regulatory interactions. Complete LIR and EM trend reports and lead tiered communication to support batch disposition. Manage the Global Lab Systems Strategy, including annual goals, long-range planning, and budget planning.
Required Qualifications
- Minimum 10 years of experience in a GMP laboratory
- Comprehensive knowledge of current regulatory requirements related to stability, raw materials, and QC operations in regulated environments
- Strong understanding of cGMP operations, testing concepts, and supporting quality systems
- Bachelor's degree or comparable experience in biological sciences, chemical sciences, business, or a similar technical field
- Experience equivalent to a Bachelor's degree or relevant experience in a regulated industry
Desired Qualifications
- Microbiology experience in quality control within a biotech, pharmaceutical, or biopharmaceutical manufacturing environment
- Prior supervisory experience
- Advanced understanding of the laboratory environment and laboratory techniques used in the analysis of biological drug products
- Strong organizational, collaboration, and communication skills
- Ability to communicate effectively with senior management and cross-functional collaborators
- Ability to work effectively across functions, levels, and teams
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