Quality Lab Supervisor

Thermo Fisher Scientific • Mebane, NC

9d

About The Position

The Quality Lab Supervisor guides quality assurance initiatives across manufacturing operations, supporting compliance and continuous improvement. The role manages quality control processes, batch record review, deviation management, and regulatory compliance to help ensure products meet required standards. It collaborates with cross-functional teams to investigate quality issues, implement corrective actions, maintain customer and regulatory relationships, and support data integrity and GMP compliance while developing team members.

The supervisor assures the quality of laboratory data and reports by supervising analytical review staff and performing Quality Control reviews. The role monitors consistent interpretation of procedural requirements and QC report content, assures compliance with FDA Good Laboratory Practices and/or GXP, and may assist with testing when priorities require it. The supervisor also oversees staff management, QC workflow and process improvement, and supports client and regulatory inspections.

Requirements

• Advanced degree plus 3 years of experience, or a bachelor's degree plus 5 years of experience, in pharmaceutical or biopharmaceutical quality assurance or quality control.
• Comprehensive knowledge of cGMP, FDA regulations, ISO standards, and other relevant regulatory requirements.
• Strong expertise in quality systems, including deviation management, CAPA, change control, and batch record review.
• Demonstrated experience supervising quality teams.
• Experience leading or participating in regulatory inspections and customer audits.
• Demonstrated success in root cause analysis and quality investigations.
• Advanced knowledge of quality risk management principles and tools.
• Excellent project management and organizational skills.
• Strong analytical and problem-solving abilities.
• Superior written and verbal communication skills in English.
• Proficiency with quality management systems and Microsoft Office applications.
• Experience with statistical analysis and quality metrics reporting.
• Ability to build collaborative relationships across functions.
• Customer-focused mindset and strong business acumen.
• Strong knowledge of SOPs and federal regulations, including GLP and GXP.
• Strong knowledge of analytical methodologies, instrumentation, and method validation.
• Thorough knowledge of divisional SOPs.
• Strong attention to detail and ability to manage multiple and changing priorities.
• Demonstrated leadership and time management skills.
• Ability to train and mentor staff.
• Travel may be required to support audits and inspections.

Nice To Haves

• Lead Auditor Certification from an accredited agency.
• Preferred fields of study include Chemistry, Biology, Pharmacy, Engineering, or a related scientific field.

Responsibilities

• Manage staff, including interviewing and selection, preparing job descriptions, supporting professional development and goal setting, managing performance, coaching and mentoring, counseling employees, and handling separations.
• Approve courses of action related to salary administration, hiring, corrective action, and terminations.
• Review and approve time records, expense reports, leave requests, and overtime.
• Coordinate with laboratory management on the priority of data and reports submitted to QC, and assign work accordingly.
• Supervise QC staff, including scheduling, interpreting procedures, and evaluating performance.
• Oversee implementation and continual improvement of QC processes, and actively participate in leadership team meetings.
• Consult with QC and laboratory staff to mediate disagreements.
• Monitor consistent interpretation of procedural requirements and QC report content.
• Evaluate QC findings, determine appropriate action, identify issues that may require follow-up inspection, and report findings to laboratory staff and management.
• Participate in client and regulatory inspections by providing information about the QC program and facilitating laboratory responses and data retrieval.
• Serve as an on-site subject matter expert for root cause analysis and CAPA, providing input and recommendations for data review and investigation processes.
• Lead client discussions regarding project quality or investigations and nonconformances related to studies.
• Assist with testing completion as priorities arise.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager