Manager, QA Compliance

US Pharma Lab • North Brunswick Township, NJ

3d • $90,000 - $105,000 • Onsite

About The Position

The Manager of Quality Assurance Compliance develops, maintains, and strengthens quality compliance programs, QA procedures, GMP and GLP compliance, regulatory inspection readiness, product testing support, quality planning, and continuous improvement initiatives. The role leads and directs the QA team and drives improvements to GMP practices, procedures, documentation standards, training, and inspection-readiness systems across the organization.

The position manages quality systems and documentation, supports product specifications and customer technical requirements, and coordinates internal and external audits and regulatory inspections. It works with cross-functional teams to resolve quality issues, monitor corrective actions, and report quality metrics to management. The role is based primarily in an office, with occasional work in warehouse or manufacturing areas where appropriate PPE is required.

Requirements

• Bachelor’s degree or higher in science or a related scientific discipline, or an equivalent combination of education and experience.
• Approximately 10–12 years of relevant work experience in the dietary supplement, nutraceutical, food, pharmaceutical, or biotech industry.
• PCQI certification is required.
• Strong knowledge of dietary supplement GMP requirements and compliance expectations, including 21 CFR Part 111, 21 CFR Part 117, GLP principles, and applicable electronic records expectations such as 21 CFR Part 11.
• Experience preparing compliance documents for customer product approval and transitioning products from development or R&D to commercial quality systems and operations according to product specifications and quality requirements.
• Hands-on experience implementing and managing quality compliance systems and processes and handling internal and external audits.
• Demonstrated ability to lead audit-readiness programs, manage third-party and regulatory audits, prepare audit responses, drive CAPA completion, and use audit outcomes to improve GMP systems and procedures.
• Strong leadership, interpersonal, problem-solving, verbal communication, and written communication skills, including the ability to identify and resolve quality issues.
• Ability to perform the described essential job functions with or without reasonable accommodation.
• Frequently sit, stand, and walk; use hands to handle writing tools and a computer keyboard; reach with hands and arms; and infrequently lift up to 30 pounds.
• Use a desk telephone or cell phone to communicate with employees.
• Wear appropriate PPE when entering warehouse or manufacturing areas.

Nice To Haves

• Hands-on Quality Assurance and Quality Compliance experience in a dietary supplement GMP manufacturing or CDMO environment is strongly preferred.
• Certifications in auditing, FSMA, HACCP, or other applicable quality and food safety programs are preferred.

Responsibilities

• Develop and maintain GxP-required SOPs and other documents in line with industry and regulatory requirements; author or approve SOPs to control GxP operations and activities.
• Periodically review established programs, including vendor qualification management, quality agreements, and annual quality management reviews; conduct or assist with internal audits of quality-controlled activities in other departments.
• Manage the preparation, review, and approval of customer specifications and related technical documents according to customer requirements and Product Development direction.
• Manage product specifications, COAs, and SDSs, and review product labels and supplement facts.
• Review or approve Food Safety Plans, validation and verification protocols and reports, and other quality-related documents.
• Oversee day-to-day QA team activities; provide GMP training, mentoring, and performance management.
• Assist Quality management during external-group, customer, and regulatory audits; develop action plans for observations and ensure adequate resolution.
• Lead quality compliance initiatives to meet current GMP expectations and improve GMP practices, procedures, documentation, training, and inspection readiness systems.
• Prepare for, host, coordinate, manage responses to, and follow up on external third-party audits and regulatory inspections, including GMP, Kosher, Halal, Organic, customer, State-authority, FDA, and TGA audits or inspections.
• Manage internal and external audits, ensuring findings are addressed and corrective actions are implemented in a timely manner.
• Document, resolve, or assist other groups with corrective actions, deviations, non-conformances, customer complaints, and change controls.
• Approve actions as necessary and monitor their effectiveness and timely completion.
• Ensure implementation of GMP procedures throughout the company.
• Collaborate with production, engineering, supply chain, and customer service to identify and resolve quality issues.
• Develop and implement quality metrics and KPIs, and regularly report performance to management.
• Perform other tasks assigned by management.

Benefits

• Medical, dental, and vision benefit options.
• Short- and long-term disability insurance.
• Basic and supplemental life insurance and AD&D insurance.
• Matched 401(k) savings plan.
• Opportunity to receive premium pay, including overtime, shift differential, and holiday pay.
• Sick time.
• Up to 10 days of vacation in the first year, increasing to 12 days starting in the second year.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager