Description:
The Senior Manager, Quality Control is responsible for overseeing activities within the quality control laboratory to ensure Quality Control Lab tasks are managed according to company procedures, and cGMP, assess business needs and make decisions based on changing conditions and manufacturing priorities.
Essential Functions:
- 15-20 years of hands-on QC experience in pharmaceutical manufacturing.
- Strong experience in Finished Products testing and Stability studies.
- Lead and manage QC operations for Finished Products and Stability studies.
- Excellent leadership, communication, and problem-solving skills.
- Ensure timely testing, review, approval, and release of finished products.
- Oversee stability sample management, execution of stability protocols, and result evaluation.
- Maintain adherence to approved specifications, SOPs, and regulatory guidelines.
- Supervise a large QC team of 50–60 analysts/supervisors.
- Allocate workloads efficiently to meet production and supply chain timelines.
- Handle regulatory inspections, customer audits, and internal audits and investigations
- Review and approve analytical documents including COAs, STPs, SOPs, protocols, and reports
- Handle performance management and recruitment. Complete annual employee performance reviews, provide performance feedback to team, assess employee skills sets for promotions, and recommend salary increases. Issue progressive disciplinary actions when necessary.
- Manage and perform investigation of out-of-specification laboratory results ensuring that all investigations proceed in a logical, orderly and timely manner; ensure appropriate root causes corrective/preventive actions are identified when necessary, review and approve investigation reports.
- Update Laboratory Procedures (SOPs) and Policies. Interpret SOPs/Methods/Specifications and provide clarity as needed. Ensure all OOS/OOAL investigations are closed in a timely manner, and SOPs are revised when due for review.
- Review and signoff process validation/cleaning validation protocols/reports, method verification/validation reports, annual product review reports. Review certificate of analysis to ensure compliance with the specifications.
- Develop and implement systems to improve laboratory GMP compliance and/or productivity. Determine process gaps, deficiencies, and implement solutions where deficiencies are found.
Research and propose capital projects for the laboratory.
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Additional Responsibilities:
- Other duties as assigned.
