Manager, QA Compliance

USPL NUTRITIONALS • North Brunswick, NJ

2d • 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 practical improvements to GMP practices, procedures, documentation standards, training, and inspection readiness across the organization.

The position manages quality documentation and programs, including GXP SOPs, vendor qualification, quality agreements, annual quality management reviews, internal audits, customer specifications, product specifications, certificates of analysis, safety data sheets, product labels, supplement facts, food safety plans, and validation and verification documents. It supports product approval and transitions from product development or R&D into commercial quality systems and operations.

The manager oversees day-to-day QA team activities, provides GMP training and mentoring, and supports audits by customers, third parties, and regulatory agencies. The role coordinates audit preparation, hosting, responses, and follow-up; manages findings and corrective actions; and works with cross-functional teams to resolve quality issues and improve compliance and operational performance. The position is primarily office-based, with occasional visits to 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.
• About 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 product development/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, including handling internal and external audits.
• Demonstrated ability to lead audit-readiness programs, manage external third-party and regulatory audits, prepare effective 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, with the ability to identify and resolve quality issues.
• Ability to perform the essential job functions with or without reasonable accommodation.

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 that control GXP operations and activities.
• Assist with or perform periodic reviews of programs such as vendor qualification management, quality agreements, and annual quality management reviews, and conduct 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 the QA team’s day-to-day activities; provide GMP training, mentoring, and performance management.
• Assist Quality management during audits conducted by external groups, customers, and regulatory agencies.
• Develop action plans to resolve documented observations and ensure adequate resolution.
• Lead Quality Compliance initiatives to meet current GMP expectations and upgrade GMP practices, procedures, documentation, training, and inspection-readiness systems.
• Prepare for, host, coordinate, manage responses to, and follow up on external third-party audits, including GMP, Kosher, Halal, Organic, and customer audits, and regulatory inspections or audits by agencies such as state authorities, FDA, and TGA.
• Manage internal and external audits, ensuring findings are addressed and corrective actions are implemented in a timely manner.
• Document and 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.
• Assure implementation of GMP procedures throughout the company.
• Collaborate with production, engineering, supply chain, customer service, and other cross-functional teams to identify and resolve quality issues.
• Develop and implement quality metrics and KPIs and regularly report performance to management.
• Perform other tasks as 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 such as 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 of employment.

What This Job Offers

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