Senior Manager, Quality Control

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.

Additional Responsibilities:

• Other duties as assigned.

Education:

• Master Degree (MS/MA) Chemistry, Microbiology, Pharmacy or other related fields - Preferred
• Bachelors Degree (BA/BS) Chemistry, Microbiology, Pharmacy or other related fields - Required

Experience:

• 12 years or more in Laboratory related with progressive increase of responsibilities in cGMP/Pharmaceutical environment in capacity of a Supervisor. (With Masters)

Specialized Knowledge:

• Must possess skills in analytical testing involving spectrophotometric analytical techniques, chromatographic techniques (HPLC/GC) employing different data acquisition software, dissolution, dissolution profile and drug release, disintegration, and moisture determination (Karl Fischer, Coulometric, LOD).
• Must be able to understand and explain compendial (USP/BP/EP/JP) procedures.
• Must be able to identify problems during the course of analysis and participate in troubleshooting of instrument-related and procedure-related problems.
• The incumbent must be able to effectively plan and organize multiple tasks with a high degree of complexity in order to complete them in a timely fashion to meet customer needs.
• Must be able to work in a cross-functional team setting, either as a leader or a member, and with complete understanding of team goals. Must understand and apply cGMP requirements applicable to pharmaceutical quality control laboratory. Must have ability to resolve conflicts between employees both within and between departments.
• Must possess skills in analytical testing involving spectrophotometric analytical techniques, chromatographic techniques (HPLC/GC) employing different data acquisition software, dissolution, dissolution profile and drug release, disintegration, and moisture determination (Karl Fischer, Coulometric, LOD).Must be able to understand and explain compendial (USP/BP/EP/JP) procedures.
• Must be able to identify problems during the course of analysis and participate in troubleshooting of instrument-related and procedure-related problems.
• The incumbent must be able to effectively plan and organize multiple tasks with a high degree of complexity in order to complete them in a timely fashion to meet customer needs. Must be able to work in a cross-functional team setting, either as a leader or a member, and with complete understanding of team goals.
• Must understand and apply cGMP requirements applicable to pharmaceutical quality control laboratory. Must have ability to resolve conflicts between employees both within and between departments.

Licenses: