QC Lab Team Supervisor

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 qualifiedreviewer forkey 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 InfraredSpectroscopy)** and **SEM/EDS (Scanning Electron Microscopy/Energy DispersiveSpectroscopy)**

• **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:

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 aplus)*

• Active involvement in regulatory and internal inspections and audit support activities

Technical Skills

• Advanced analytical skills with the ability toanalyzecomplex 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 abovetarget)*

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 grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks’gender-neutral parental leave.

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply. 

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale 

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime. 
  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race;color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or militarystatus or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.