QA Leader, FDA-Regulated Life Sciences

ACE Partners; Pohatcong Township (NJ); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

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Job summary

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

You will lead the QA team, manage CAPA/NCR, conduct internal QMS audits, ensure cGMP compliance, and collaborate with customers, suppliers, and production to uphold quality standards.

Qualifications

• Bachelor's degree in life science or equivalent experience.
• 5+ years of quality systems experience in regulated manufacturing.
• Strong knowledge of FDA and international quality regulations.
• Supervisory experience preferred.
• Excellent communication and leadership skills.

Responsibilities

• Lead, train, and develop the Quality Assurance team.
• Direct CAPA/NCR program 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 for quality requirements.
• Provide strategic quality insight to senior management and drive continuous improvement.

Skills

Quality leadership

CAPA & NCR

QMS audits

Regulatory compliance

Cross-functional collaboration

Communication

Education

Bachelor's degree in life science

Job description

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

You will lead the QA team, manage CAPA/NCR, conduct internal QMS audits, ensure cGMP compliance, and collaborate with customers, suppliers, and production to uphold quality standards.