Quality Lab Lead: GMP, CAPA & Compliance

Regulatory Jobs; Mebane (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality Lab Supervisor to guide quality assurance across pharmaceutical manufacturing operations. You will lead deviation management, CAPA, batch review and regulatory compliance while fostering continuous improvement and data integrity.

Collaboration with cross‑functional teams and strong client/regulatory liaison will be essential. The role requires FDA GLP/GXP familiarity, leadership of QA staff, and effective communication in English.

Qualifications

• Advanced degree plus 3 years of experience in pharmaceutical/biopharmaceutical QA or QC.
• Bachelor's degree plus 5 years of experience in pharmaceutical/biopharmaceutical QA or QC.
• Lead Auditor Certification from an accredited agency preferred.
• Knowledge of cGMP, FDA regulations, ISO standards and other regulatory requirements.
• Experience with deviation management, CAPA, change control, and batch record review.
• Demonstrated leadership supervising quality teams.
• Experience in regulatory inspections and customer audits.
• Root cause analysis and quality investigations experience.
• Quality risk management principles and tools knowledge.
• Excellent project management and organizational skills.
• Strong verbal and written communication in English.
• Experience with quality management systems and MS Office; statistical analysis and quality metrics reporting.

Responsibilities

• Manage staff selection, development, performance, and payroll actions.
• Supervise QC staff scheduling, interpretation of procedures, and performance reviews.
• Oversee QC processes and lead leadership team meetings.
• Mediating disputes between QC and laboratory staff.
• Evaluate QC findings and determine follow-up actions.
• Support client and regulatory inspections and data retrieval.
• Act as on-site expert for CAPA and root cause analysis in studies.

Skills

SOPs & Regs

Analytical methods

Divisional SOPs

Communication skills

Attention to detail

Priorities management

Leadership & time mgmt

Mentoring

Education

Advanced degree + 3 yrs in QA/QC

Bachelor's degree + 5 yrs in QA/QC

Prefered fields: Chemistry, Biology, Pharmacy, Engineering

Job description

Thermo Fisher Scientific is seeking a Quality Lab Supervisor to guide quality assurance across pharmaceutical manufacturing operations. You will lead deviation management, CAPA, batch review and regulatory compliance while fostering continuous improvement and data integrity.

Collaboration with cross‑functional teams and strong client/regulatory liaison will be essential. The role requires FDA GLP/GXP familiarity, leadership of QA staff, and effective communication in English.