Senior Manager - Quality Control

Position Summary

The Manager, Finished Product & Stability Quality Control is responsible for leading all analytical testing, stability program execution, laboratory compliance activities, investigations, and personnel management associated with Finished Product and Stability testing. The role ensures compliance with cGMP, FDA, ICH, USP, Data Integrity, and internal quality requirements while supporting product release, stability commitments, regulatory inspections, and continuous improvement initiatives.

Key Responsibilities

• Manage Finished Product and Stability testing activities to support commercial product release and ongoing stability programs.
• Oversee testing and review of assay, related substances, chromatographic purity, degradation products, dissolution, content uniformity, residual solvents, and other compendial requirements.
• Ensure timely execution of stability sample pulls, testing, data review, trending, and reporting activities.
• Lead laboratory investigations including OOS, OOT, deviations, atypical results, and CAPA implementation.
• Review and approve analytical data, laboratory records, chromatograms, and technical reports.
• Support method verification, method transfer, process validation, cleaning validation, and troubleshooting activities.
• Ensure inspection readiness and actively support regulatory and customer audits.
• Supervise, train, mentor, and develop laboratory personnel while ensuring efficient workload distribution and resource utilization.
• Partner with QA, Manufacturing, Validation, Regulatory Affairs, Supply Chain, and R&D to meet business and compliance objectives.

Required Qualifications & Experience

• Bachelor's or Master's Degree in Chemistry, Pharmaceutical Sciences, or related scientific discipline.
• Minimum 5+ years of pharmaceutical Quality Control experience with at least 3-5 years in a supervisory or managerial role.
• Strong experience supporting FDA-regulated pharmaceutical manufacturing environments.

Technical Knowledge & Competencies

• Hands-on experience in Finished Product and Stability sample testing within a pharmaceutical Quality Control laboratory. Experience with Raw Material testing is preferred.
• Strong knowledge of chromatographic techniques including assay testing, related substances (impurity profiling), degradation product analysis, and chromatographic purity determination using HPLC, UPLC, GC, and IC systems.
• Proficient in operation, troubleshooting, and lifecycle management of analytical instruments including HPLC, UPLC, GC, IC, Dissolution Testers, Karl Fischer, FTIR, UV-Vis, and XRPD.
• Thorough understanding of Oral Solid Dosage (OSD) product testing requirements and regulatory expectations.
• Strong technical expertise in pharmaceutical analytical methodologies, laboratory investigations, data review, and compliance-driven laboratory operations.
• Working knowledge of cGMP, GLP, GDP, Data Integrity requirements, USP, ICH guidelines, and FDA expectations.
• Experience with chromatography data systems and laboratory software including Empower, LabSolutions, Tiamo, and other computerized laboratory systems.
• Working knowledge of Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebook (ELN), and Quality Management Systems such as TrackWise.
• Demonstrated experience in method execution, method troubleshooting, data review, technical assessments, and investigation management.
• Experience supporting regulatory inspections and customer audits, including USFDA, customer, and corporate audits.
• Strong leadership, communication, documentation, decision-making, and problem-solving skills with the ability to effectively manage teams and collaborate across functions.