GMP QA Manager — Analytical Lab, Mon-Fri

Pace Analytical Services LLC; Lebanon (NJ); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Health, dental, vision benefits

401(k) with company match

Paid time off & holidays

Tuition reimbursement

Employee Assistance program

Job summary

Pace Life Sciences in Lebanon, NJ is seeking a Quality Assurance Manager to lead the QMS and ensure regulatory compliance across analytical operations and GMP testing. This role emphasizes collaboration with operations to meet business needs and drive continuous improvement.

The ideal candidate has a hands-on quality background in pharmaceutical labs or CDMOs, with strong data integrity and audit experience, plus 3+ years of leadership.

Qualifications

• Bachelor's degree in a scientific discipline.
• 7+ years of Quality Assurance experience in pharma/biotech/CDMO environments.
• 3+ years of leadership or people management experience.
• Strong knowledge of FDA regulations, cGMP, ICH guidelines, and data integrity principles.

Responsibilities

• Oversee and maintain the Quality Management System (QMS) and KPIs.
• Ensure compliance with regulatory requirements (FDA, ICH, ISO, cGMP).
• Lead QA oversight of analytical operations and GMP testing.
• Review documentation, investigations, and quality records; support method validation and transfer.
• Lead audits and client/regulatory inspections; manage CAPAs and change controls.
• Drive continuous improvement and staff development.

Skills

Quality Assurance

Leadership

FDA regulations

cGMP

Data Integrity

Audits

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related

Tools

eQMS

Job description

Pace Life Sciences in Lebanon, NJ is seeking a Quality Assurance Manager to lead the QMS and ensure regulatory compliance across analytical operations and GMP testing. This role emphasizes collaboration with operations to meet business needs and drive continuous improvement.

The ideal candidate has a hands-on quality background in pharmaceutical labs or CDMOs, with strong data integrity and audit experience, plus 3+ years of leadership.