QA Manager — FDA-Regulated Life Sciences

ACE Partners; Pohatcong Township (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

ACE Partners is partnering with a leading life sciences manufacturer to hire a Quality Assurance Manager at their site in New Jersey. This hands-on leadership role oversees QA operations within an FDA-regulated manufacturing environment.

The role leads, trains, and develops the QA team, directs CAPA and NCR activities, and ensures cGMP, FDA, IPEC, and ISO compliance while collaborating with customers and production leadership on quality improvements.

Qualifications

• Bachelor's degree in life science required.
• 5+ years of progressive Quality Systems experience in a regulated manufacturing environment.
• Strong working knowledge of FDA and international quality regulations.
• Supervisory experience preferred.
• Excellent communication, organizational, and leadership skills.

Responsibilities

• Lead, train, and develop the Quality Assurance team.
• Direct the CAPA/NCR program and lead complaint investigations and root cause analysis.
• Conduct internal QMS audits and maintain cGMP compliance.
• Ensure alignment with FDA, IPEC, and ISO requirements.
• Partner with customers, suppliers, and production leaders on quality requirements and corrective actions.

Skills

Leadership

Regulatory knowledge

Quality Systems

Communication

Education

Bachelor's degree in Life Science

Job description

ACE Partners is partnering with a leading life sciences manufacturer to hire a Quality Assurance Manager at their site in New Jersey. This hands-on leadership role oversees QA operations within an FDA-regulated manufacturing environment.

The role leads, trains, and develops the QA team, directs CAPA and NCR activities, and ensures cGMP, FDA, IPEC, and ISO compliance while collaborating with customers and production leadership on quality improvements.