Quality Assurance and Regulatory Affairs Manager

The Quality Assurance & Regulatory Affairs Manager will oversee compliance, regulatory submissions, and quality systems across manufacturing. This role ensures that all products meet FDA, FTC, DSHEA, and international standards while driving continuous improvement in food safety and GMP practices. The ideal candidate combines deep regulatory knowledge with leadership skills to guide teams, support product development, and safeguard brand reputation.

Client Details

Our client is a premier contract manufacturer specializing in dietary supplements and nutritional products. With a state-of-the-art, cGMP-certified facility and an in-house R&D team, the company partners with leading and emerging brands to deliver innovative formulations, scalable production, and turnkey solutions. Known for its commitment to quality, compliance, and sustainable growth, this organization offers a collaborative environment where employees play a critical role in ensuring product integrity and regulatory excellence.

Description

• Ensure compliance with FDA (21 CFR 111), DSHEA, FTC, and global supplement regulations.

• Review/approve labels, claims, and marketing for regulatory accuracy.

• Maintain product dossiers, master files, and ingredient safety documentation.

• Manage agency submissions, audits, and client certifications (e.g., NSF, Organic, Kosher)

• Provide regulatory guidance during product development and commercialization

• Monitor evolving regulations and communicate impacts to stakeholders

• Oversee QMS aligned with cGMP, HACCP, ISO, and sanitation standards

• Lead internal, client, and regulatory audits, driving corrective actions

• Investigate quality incidents, CAPAs, deviations, and complaints

• Develop SOPs, batch records, and product specifications

• Manage supplier qualifications, lab performance, and raw material oversight

• Train staff on GMP compliance, QA systems, and best practices

• Track KPIs, analyze trends, and implement process improvements

Profile

• Bachelor's degree in Life Sciences, Chemistry, Nutrition, Food Science, or related field (Master's preferred)

• 5+ years in QA/Regulatory compliance management within dietary supplement/food manufacturing

• Strong knowledge of FDA 21 CFR Part 111, DSHEA, FTC, USDA, HACCP, GMP, and ISO standards

• Hands-on experience with audits, documentation control, and CAPA management

• Excellent organizational, communication, and leadership skills

Job Offer

• Bonus eligibility

• Medical, dental, vision, and life insurance coverage

• 401(k) with company match

• Paid time off and holidays

• Education reimbursement and professional development opportunities

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.