Senior QC Lab Supervisor & Compliance Lead

BioSpace; Swiftwater (Monroe County); On-site; USD 110,000 - 140,000; Full time

Job summary

Sanofi Inc. in Swiftwater, PA is seeking a QC Lab Team Supervisor to lead the quality control laboratory and ensure product quality and patient safety in a pharmaceutical manufacturing setting.

The role requires hands-on experience from technician roles to laboratory management, with strong GMP knowledge and ability to drive continuous improvement while maintaining regulatory compliance. You will mentor staff, oversee testing across multiple methods, and support internal and external audits.

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.
• 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 GMP and regulatory requirements (FDA, EMA, ICH guidelines).
• Hands-on expertise in Particulate Isolation, Micro-FTIR, and SEM/EDS analysis within a regulated pharmaceutical environment.
• Experience authoring and reviewing technical reports, memorandums, and quality documents.
• Experience in a regulated compendial testing environment (USP/EP/JP standards aplus).

Responsibilities

• Oversee daily QC lab operations to ensure adherence to 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 production and operational timelines.
• Serve as a qualified reviewer for key testing areas to maintain testing coverage (e.g., Wet Chemistry, FTIR, SEM/EDS).
• Maintain the laboratory in compliance with GMPs and quality control processes.
• Author and review quality documents as a technical reviewer (procedures, reports, CAPAs).
• Support audits through scribing, documentation support, and management walkthroughs.

Skills

Leadership

Quality control

GMP compliance

Lab management

Education

Bachelor's degree in Life Sciences

Tools

LIMS (LabWare)

SAP

Trackwise

iLearn

Qualipso

Job description

Sanofi Inc. in Swiftwater, PA is seeking a QC Lab Team Supervisor to lead the quality control laboratory and ensure product quality and patient safety in a pharmaceutical manufacturing setting.

The role requires hands-on experience from technician roles to laboratory management, with strong GMP knowledge and ability to drive continuous improvement while maintaining regulatory compliance. You will mentor staff, oversee testing across multiple methods, and support internal and external audits.