QA Compliance Manager – GMP & Regulatory Readiness

Biofarma Group; North Brunswick Township (NJ); On-site; USD 90,000 - 105,000; Full time

Job summary

Biofarma Group in North Brunswick, NJ is seeking a Manager, Quality Assurance Compliance to lead GMP/GLP compliance, QA procedures, and regulatory inspection readiness. This Exempt, full-time role reports to the Vice President of Quality Assurance and drives continuous improvement across quality systems.

The position requires PCQI certification and 10–12 years of QA experience in a dietary supplement, nutraceutical, or pharmaceutical environment, with strong audit and CAPA skills.

Qualifications

• Bachelor’s Degree or higher in science or related disciplines.
• About 10-12 years of relevant work experience in dietary supplement, nutraceutical, food, pharmaceutical, or biotech industry, with strong preference for QA/QC in GMP environments.
• PCQI certification is required; certifications in auditing, FSMA, HACCP, or other quality programs preferred.

Responsibilities

• Develop and maintain SOPs ensuring GXP compliance and control of operations.
• Coordinate internal and external audits, prepare responses, and drive CAPA closure.
• Review customer specifications and technical docs per product development direction.
• Manage product specs, COAs, SDS, and label reviews to ensure compliance.
• Lead audit readiness programs and support regulatory inspections or third-party audits.

Skills

GMP compliance

GLP compliance

QA leadership

Audit readiness

CAPA management

Regulatory inspections

Documentation control

GXP SOPs

21 CFR Part 111

21 CFR Part 117

21 CFR Part 11

Education

Bachelor’s Degree or higher in science

10–12 years QA experience

Job description

Biofarma Group in North Brunswick, NJ is seeking a Manager, Quality Assurance Compliance to lead GMP/GLP compliance, QA procedures, and regulatory inspection readiness. This Exempt, full-time role reports to the Vice President of Quality Assurance and drives continuous improvement across quality systems.

The position requires PCQI certification and 10–12 years of QA experience in a dietary supplement, nutraceutical, or pharmaceutical environment, with strong audit and CAPA skills.