QC Lab Lead: GMP & Team Excellence

Sanofi; Swiftwater (Monroe County); On-site; USD 105,000 - 135,000; Full time

Job summary

Sanofi is seeking a QC Lab Team Supervisor in Swiftwater, PA to lead daily QC laboratory operations, drive quality control and regulatory compliance, and mentor staff. The role requires extensive hands-on experience across QC methods, instrumentation, audits, and continuous improvement initiatives.

The successful candidate will manage testing schedules, ensure assay accuracy, collaborate with production, and uphold cGMP standards in a fast-paced pharmaceutical environment.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering or related field with at least 8 years of experience in a cGMP environment.
• Progressive QC experience spanning technician through leadership and management roles.
• Strong knowledge of GMP and regulatory requirements (FDA, EMA, ICH).
• Hands-on expertise in Particulate Isolation, Micro-FTIR, and SEM/EDS within a regulated setting.
• Experience authoring and reviewing technical reports and quality documents.
• Involvement with regulatory and internal inspections and audits.

Responsibilities

• Oversee daily operations of the quality control laboratory to ensure adherence to scheduled plans
• Conduct routine shopfloor reviews 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 testing areas to maintain coverage, including Wet Chemistry, HPLC, LCMS, CCIT, BLGF, FTIR, SEM/EDS
• Maintain GMP compliance and quality systems across lab processes
• Investigate quality events, CAPAs, deviations, and corrective actions
• Author and review quality documents and participate in audits and inspections
• Lead training and development of QC staff and support interview processes
• Maintain laboratory equipment, calibration programs, and qualification plans

Skills

GMP knowledge

Quality control

Leadership

Regulatory compliance

Analytical skills

Laboratory instrumentation

Method validation

Continuous improvement

Lean initiatives

LIMS experience

Education

Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering or related field

Tools

LIMS (LabWare)

Trackwise

SAP

iLearn

OPSTRakker

Qualipso

Adobe Software Suite

Job description

Sanofi is seeking a QC Lab Team Supervisor in Swiftwater, PA to lead daily QC laboratory operations, drive quality control and regulatory compliance, and mentor staff. The role requires extensive hands-on experience across QC methods, instrumentation, audits, and continuous improvement initiatives.

The successful candidate will manage testing schedules, ensure assay accuracy, collaborate with production, and uphold cGMP standards in a fast-paced pharmaceutical environment.