Senior QA Manager, GMP Analytics & Compliance

Pace Analytical Services, LLC; Lebanon (NJ); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Annual bonus

Health benefits

401(k) with company match

Paid time off

Career growth opportunities

Collaborative work environment

Job summary

Pace Life Sciences in Lebanon, NJ, is seeking a full-time Quality Assurance Manager to oversee the Quality Management System (QMS) and ensure compliance with FDA, ICH, ISO, and cGMP regulations. You will lead QA activities supporting analytical testing, audits, documentation, and continuous improvement.

The ideal candidate has 7+ years in QA within pharmaceutical/biotech/CDMO environments, with 3+ years in leadership, strong data integrity and problem-solving skills, and a hands-on approach to

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 7+ years of Quality Assurance experience in a pharmaceutical, biotechnology, CDMO, or contract analytical laboratory environment.
• 3+ years of leadership or people management experience.
• Strong knowledge of FDA regulations, cGMP requirements, ICH guidelines, and data integrity.

Responsibilities

• Oversee and maintain the Quality Management System (QMS) to ensure compliance with applicable FDA, ICH, USP, ISO and cGMP regulations.
• Lead QA activities supporting analytical testing operations, client programs, laboratory compliance, documentation review, audits, change management, investigations, and continuous improvement initiatives.
• Review and approve analytical documentation, protocols, reports, investigations, and quality records.
• Support method validation, method transfer, stability studies, and analytical development programs.
• Ensure data integrity practices align with ALCOA+ principles and regulatory expectations.

Skills

QA leadership

Regulatory knowledge

Documentation review

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 full-time Quality Assurance Manager to oversee the Quality Management System (QMS) and ensure compliance with FDA, ICH, ISO, and cGMP regulations. You will lead QA activities supporting analytical testing, audits, documentation, and continuous improvement.

The ideal candidate has 7+ years in QA within pharmaceutical/biotech/CDMO environments, with 3+ years in leadership, strong data integrity and problem-solving skills, and a hands-on approach to