Quality Lab Supervisor

Thermo Fisher Scientific•Mebane, NC

10d

About The Position

The Quality Lab Supervisor assures the quality of laboratory data and reports by supervising analytical review staff and performing Quality Control (QC) reviews. The role monitors consistent interpretation of procedural requirements and QC report content, ensures compliance with FDA Good Laboratory Practices and/or GXP, and may assist with testing as priorities arise. The position guides quality assurance initiatives across manufacturing operations and supports compliance and continuous improvement. It manages quality control processes, batch record review, deviation management, and regulatory compliance; collaborates across functions to investigate quality issues and implement corrective actions; supports data integrity and GMP compliance; and develops team members. The supervisor also oversees QC processes and staff, evaluates findings, supports client and regulatory inspections, and serves as an on-site subject matter expert for root cause analysis and CAPA.

Requirements

Advanced degree plus 3 years of experience, or a bachelor's degree plus 5 years of experience in pharmaceutical/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 leadership 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 with 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, and 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: Chemistry, Biology, Pharmacy, Engineering, or a related scientific field.

Responsibilities

Manage staff, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
Approve courses of action on 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, procedural interpretation, and performance evaluation.
Oversee implementation and continual improvement of QC processes and participate in leadership team meetings.
Consult with QC and laboratory staff to mediate disagreements and monitor consistency in interpreting procedural requirements and QC report content.
Evaluate QC findings, determine appropriate action, identify issues requiring follow-up inspection, and report findings to laboratory staff and management.
Participate in client and regulatory inspections, provide information about the QC program, facilitate lab responses, and retrieve data.
Serve as an on-site subject matter expert for root cause analysis and CAPA, and provide input and recommendations for data review or investigation processes.
Lead client discussions regarding project quality or investigations and nonconformances related to studies.
Assist with testing completion as priorities arise.