Quality Assurance Manager – GMP Analytical Lab

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

Benefits offered by this job

Annual bonus

Health benefits

401(k) plan

Paid time off

Professional development

Collaborative environment

Job summary

Pace® Analytical Services is seeking a Quality Assurance Manager in Lebanon, NJ. The role oversees the QMS, ensures GMP compliance, and leads QA activities for analytical testing, audits, and continuous improvement.

The ideal candidate has strong GMP knowledge and the ability to collaborate with operations to meet business needs. The position requires 7+ years in QA in pharmaceutical/contract labs, 3+ years of leadership, and expertise in deviations, CAPAs, change controls, and data integrity.

Qualifications

• 7+ years of Quality Assurance experience in pharma/biotech/CDMO or contract analytical lab.
• 3+ years of leadership or people management experience.
• Strong knowledge of FDA regulations, cGMP, ICH, and Data Integrity.
• Experience managing deviations, CAPAs, change controls, and investigations.
• Excellent written and verbal communication, organizational skills.

Responsibilities

• Oversee and maintain the Quality Management System (QMS) and report KPIs.
• Provide QA oversight of analytical lab operations and GMP testing.
• Review and approve analytical documents, protocols, reports, investigations, and quality records.
• Support method validation/transfer, stability studies, and analytical development.
• Lead internal audits, client/regulatory inspections, and supplier audits.
• Develop and mentor QA team; drive continuous improvement in quality and compliance.

Skills

QA leadership

GMP knowledge

FDA regulations

Data integrity

Documentation review

Analytical lab operations

Education

Bachelor's degree in Chemistry/ Biology/ Pharmaceutical Sciences

Tools

eQMS

Job description

Pace® Analytical Services is seeking a Quality Assurance Manager in Lebanon, NJ. The role oversees the QMS, ensures GMP compliance, and leads QA activities for analytical testing, audits, and continuous improvement.

The ideal candidate has strong GMP knowledge and the ability to collaborate with operations to meet business needs. The position requires 7+ years in QA in pharmaceutical/contract labs, 3+ years of leadership, and expertise in deviations, CAPAs, change controls, and data integrity.