Associate Director, QA Compliance & GMP Readiness

Biofarma Group; North Brunswick Township (NJ); On-site; USD 125,000 - 141,000; Full time

Job summary

Biofarma Group in North Brunswick, NJ seeks an Associate Director of Quality Assurance Compliance to lead GMP/GLP compliance programs, audit readiness, and quality systems enhancements. This role directs the QA team and collaborates with production, engineering, and supply chain to sustain regulatory compliance.

The position requires a strong background in dietary supplement/pharma QA, PCQI certification, and extensive experience with audits and CAPA management.

Qualifications

• Bachelor’s degree or higher in science or related field.
• 10–12 years of QA/Quality Compliance experience in dietary supplement/pharma.
• PCQI certification is required.
• Experience with audits and GMP/GLP.

Responsibilities

• Develop and maintain GXP required SOPs and other documents; approve SOPs.
• Oversee internal and external audits and prepare audit responses.
• Lead quality compliance initiatives and inspection readiness.
• Collaborate with cross-functional teams to resolve quality issues.
• Manage CAPA, deviations, non-conformances and change controls.

Skills

GMP knowledge

21 CFR Part 111

21 CFR Part 117

GLP principles

21 CFR Part 11

Audit management

Leadership

Communication

Education

Bachelor’s degree or higher in science

Equivalent combination of education and experience

Job description

Biofarma Group in North Brunswick, NJ seeks an Associate Director of Quality Assurance Compliance to lead GMP/GLP compliance programs, audit readiness, and quality systems enhancements. This role directs the QA team and collaborates with production, engineering, and supply chain to sustain regulatory compliance.

The position requires a strong background in dietary supplement/pharma QA, PCQI certification, and extensive experience with audits and CAPA management.