QA Compliance Leader - GMP & Audit Readiness

US Pharma Lab, Inc.; New Brunswick (NJ); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health and wellness benefits

401(k) savings plan

Paid vacation days

Job summary

US Pharma Lab, Inc. seeks a Manager, Quality Assurance Compliance to lead the development and maintenance of quality compliance programs across GMP and GLP operations.

You will guide QA procedures, inspection readiness, and internal audits, while mentoring the QA team and driving continuous improvement in documentation standards. The role requires extensive experience (10–12 years) in dietary supplement/pharma settings, PCQI certification, and strong leadership abilities to manage audits and

Qualifications

• Bachelor's Degree or higher in science or related scientific disciplines.
• About 10-12 years of relevant work experience in the dietary supplement, nutraceutical, food, pharmaceutical, or biotech industry, with strong preference for hands-on Quality Assurance and Quality Compliance experience in a Dietary Supplement GMP manufacturing or CDMO environment.
• Or equivalent combination of education and experience.

Responsibilities

• Develop and maintain GXP SOPs and related documents in line with regulatory requirements.
• Assist in / perform periodic reviews of programs including Vendor qualification and Quality Agreements; conduct internal quality audits.
• Approve customer specifications and related technical documents per Product Development direction.
• Manage product specifications, COAs, SDS, and label review.
• Review and approve Food Safety Plans, validation/verification protocols and reports.
• Oversee day-to-day QA activities, provide GMP training, mentoring and performance management.
• Support audits by external groups, customers and regulators; develop action plans to resolve observations.
• Lead Quality Compliance initiatives to meet GMP expectations and upgrade practices and inspection readiness systems.
• Prepare, host and coordinate external audits (GMP, Kosher, Halal, Organic, customer, regulatory) and follow up.
• Manage internal/external audits, ensure corrective actions are timely.
• Document and assist with Corrective Actions, Deviations, Non-Conformance, Customer Complaints and Change Controls.
• Approve actions and monitor effectiveness.
• Ensure GMP procedures are implemented across the company.
• Collaborate with cross-functional teams to identify and resolve quality issues.
• Develop and report quality metrics and KPIs to management.

Skills

Leadership

QA & Compliance

Auditing

Problem solving

Communication

GxP knowledge

Education

Bachelor's Degree or higher in science

Equivalent education/experience

Job description

US Pharma Lab, Inc. seeks a Manager, Quality Assurance Compliance to lead the development and maintenance of quality compliance programs across GMP and GLP operations.

You will guide QA procedures, inspection readiness, and internal audits, while mentoring the QA team and driving continuous improvement in documentation standards. The role requires extensive experience (10–12 years) in dietary supplement/pharma settings, PCQI certification, and strong leadership abilities to manage audits and