Group Manager - Quality Control

Start free →

Or apply yourself on the official page →

About the role

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work. What You Will Achieve In this role, you will: • Leadership & People Management • Lead, coach, and manage Quality Control teams through goal setting, performance reviews, feedback, development planning, and succession readiness. • Identify development needs, foster teamwork, inclusion, and a culture of accountability and continuous improvement. • Manage workforce planning, leave management, and performance appraisal cycles. • Actively share knowledge, encourage innovation, and support risk‑based decision making. • Quality Control & Laboratory Operations • Plan, manage, and oversee analytical activities related to: • In‑process, finished product, stability, process validation, exhibit batch, market complaint, and retention sample testing • Stability sample pulling, testing, protocol approval, compilation reports, and annual stability report submissions • Visual inspection of retention samples per approved schedules • Ensure timely review, approval, and completion of all QC activities in alignment with site KPIs. • Review and approve, Laboratory investigations, QC documentation including raw data, protocols, reports, and SOPs in compliance with cGMP. • Equipment Qualification, Calibration & Lifecycle Management • Ensure equipment qualification and lifecycle compliance for QC laboratory instruments, including IQ/OQ/PQ activities. • Oversee calibration, preventive maintenance, and requalification of QC equipment in accordance with approved schedules and regulatory requirements. • Ensure Equipment Qualification protocols, reports, deviations, and change controls are reviewed and approved. • Collaborate with Engineering, Validation, and QA to support: • New equipment introduction • Decommissioning and replacement activities • Qualification impact assessments for changes • Ensure data integrity, ALCOA+ principles, and computerized system compliance for analytical instrumentation. • Stability Management • Approve and manage stability and retention sample requests, protocols, reports, and annual submissions. • Ensure sponsor‑site stability samples, review of shipment temperature excursions, and execution of stability studies at site. • Ensure PRQ and qualification of stability chambers as per approved schedules. • Compliance, Audits & Quality Systems • Ensure alignment with cGMP, regulatory requirements, and Pfizer Quality Standards across all QC activities. • Represent CQ during internal, external, customer, and regulatory audits and inspections. • Support timely investigation and closure of Incidents, Deviations, CAPAs, and Change Controls, including cross‑functional impact assessments. • Ensure personnel safety, safe material handling, and adherence to EHS requirements within QC laboratories. • Continuous Improvement & Technical Excellence • Guide analysts in the application of continuous improvement tools such as standard work, visual management, LEAN, and Six Sigma methodologies. • Drive simplification, digitization, and efficiency improvement initiatives across CQ processes. • Provide technical expertise in troubleshooting analytical methods, inst

View the official posting →