QC Lab Team Supervisor

Job description

Job Title: QC Lab Team Supervisor Location: Swiftwater, PA About the Job: The Quality Control Laboratory Team Supervisor plays a pivotal role in ensuring the highest standards of product quality and patient safety within a pharmaceutical/vaccine manufacturing environment. This position is ideally suited for a seasoned QC laboratory professional who has demonstrated progressive growth through hands-on technician roles, training management, and laboratory management responsibilities. The successful candidate will bring proven expertise in quality control operations, regulatory compliance, and team leadership — with a track record of driving continuous improvement while maintaining strict adherence to internal and external GMP requirements. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities: 1. Laboratory Operations Management Oversee daily operations of the quality control laboratory to ensure adherence to committed scheduled plans Conduct routine shopfloor reviews of the laboratory to identify improvement opportunities Ensure accurate and timely testing of received samples according to designated perimeter Assist in scheduling laboratory work to meet the demands of production and operational timelines Serve as a qualified reviewer for key testing areas to maintain operational continuity and testing coverage, including but not limited to: Wet Chemistry, Electrophoresis, HPLC, LCMS, CCIT, BLFG, ICP, FTIR, GC, MALs, and SEM/EDS. 2. Compliance & Quality Assurance Maintain the laboratory in compliance with GMPs and quality control processes defined according to internal and external quality requirements and regulations. Ensure the use of validated methods within the designated perimeter and execute any validation/transfer protocol as receiving unit. Investigate in a timely manner and resolve any quality control events, issues, or discrepancies from the designated perimeter. Implement remediation actions from findings and CAPAs (Corrective and Preventive Actions) Author and review quality documents as a technical reviewer, including procedure revisions, protocols, reports, change controls, CAPAs, and deviations Support internal and external audits through scribing, backroom documentation support, and participation in management walkthroughs for audit preparation and readiness. Investigate customer product complaints and conduct deviation investigations, including interpretation and reporting of results Assist with logbook creation, certification, logbook review, stability dispensing laboratory operations, and file retention management. 3. Team Leadership & Development Manage and train laboratory staff, ensuring they follow best practices and safety guidelines Ensure laboratory staff is qualified to perform testing execution by maintaining the lab qualification matrix Foster a culture of continuous improvement and high performance Oversee training compliance Actively mentor colleagues to support professional development opportunities Participate in the interview and selection process for new hires, including QC production workers, salaried employees, and interns 4. Technical Operations Maintain laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities Ensure lab facilities and instruments are kept in a quality and safety status to ensure appropriate use Apply deep, hands-on expertise in specialized techniques including: **Particulate Isolation and Characterization** using optical microscopy, photographic analysis, and **Micro-FTIR** **FTIR (Fourier Transform Infrared Spectroscopy)** and **SEM/EDS (Scanning Electron Microscopy/Energy Dispersive Spectroscopy)** **Container Closure Integrity Testing (CCIT)** **BLGF Testing** Author technical memorandums and reports 5. Laboratory & Quality Systems Demonstrate proficiency in laboratory and quality management systems including: **Opstrakker, Qualipso, iLearn, SAP, LIMS (LabWare), Trackwise,** and the **Adobe Software Suite** About You: Basic qualifications: Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering or a related scientific field with at least 8 years of experience in a cGMP environment. Experience Progressive QC experience within a pharmaceutical or vaccine manufacturing environment, spanning roles from laboratory technician through training management and laboratory management levels Comprehensive knowledge of **Good Manufacturing Practices (GMP)** and regulatory requirements (FDA, EMA, ICH guidelines) Direct, hands-on expertise in **Particulate Isolation, Micro-FTIR, and SEM/EDS** analysis within a regulated pharmaceutical environment Demonstrated experience authoring and reviewing technical reports, memorandums, and quality documents Experience in a regulated compendial testing environment *(USP/EP/JP standards a plus)* Active involvement in regulatory and internal inspections and audit support activities Technical Skills Advanced analytical skills with the ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement Proficiency in identifying issues and implementing effective solutions to resolve quality control problems Expert knowledge of laboratory instrumentation, maintenance, qualification, and calibration procedures Strong understanding of method validation and transfer protocols Proficiency in laboratory information management systems (LIMS) and quality systems (Trackwise, SAP, iLearn, etc.) Experience with **continuous improvement and Lean initiatives**, including tracking cost and efficiency metrics, is a differentiating strength *(e.g., demonstrated revenue/efficiency performance above target)* Leadership & Soft Skills Strong leadership abilities to manage and motivate a team, ensuring high performance and adherence to quality standards Excellent written and verbal communication skills Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements Ability to work effectively under pressure and manage multiple priorities Strong problem-solving and critical thinking capabilities Commitment to continuous improvement and quality excellence Health, Safety & Environment (HSE) — Valued Asset Experience serving as an **HSE safety representative or correspondent**, including conducting regular lab area inspections as preventative actions Demonstrated experience performing monthly **GEMBA walks** and **Satellite Accumulation Area inspections** Experience facilitating safety initiatives, presenting safety communications, and driving action item completion within a QC department Ability to provide safety metrics for department-level meetings (L1, L2, QDCI) and serve as backup to the QC HSE manager Strong commitment to maintaining a safe laboratory environment as a core operational priority Working Conditions Laboratory environment with exposure to chemicals and specialized equipment May require the use of personal protective equipment (PPE) Standard working hours with flexibility based on operational needs, i.e. overtime may be required Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to gr