A leading contract manufacturer of dietary supplements is seeking a Quality Assurance Director to oversee safety, consistency, and regulatory compliance for its growing operation. Specializing in capsules, tablets, powders, and functional foods, the company partners with top nutraceutical brands to deliver high-quality, science-backed products. This role ensures that all manufacturing processes meet customer specifications, cGMP, and FDA regulations, while fostering a culture of quality and continuous improvement across departments.
Key Responsibilities:
Lead Quality Assurance & Regulatory Affairs for a dietary supplement manufacturing facility, ensuring compliance with local, state, and federal food safety standards.
Develop, implement, and continuously improve cGMP, GLP, 21 CFR Part 111, HACCP, FSMA, and Organic compliance programs.
Oversee internal, external, and regulatory audits, resolving quality and food safety issues with effective solutions.
Collaborate with R&D and Manufacturing to support product development, scale-up, and testing.
Manage quality documentation, including batch release, raw material qualification, and regulatory filings.
Implement supplier qualification programs, including supplier audits and compliance verification.
Lead investigations for non-conformances, out-of-spec results, and corrective actions (CAPAs).
Ensure timely resolution of customer complaints, audit findings, and inquiries.
Direct quality control sampling, testing, and facility audits to maintain compliance with internal and external standards.
Recruit, train, and lead quality assurance staff, fostering a culture of quality and continuous improvement.
Maintain regulatory compliance for product labeling, including NFPs, SFPs, and label claims.
Develop and manage an in-house product testing lab for composition and microbial testing.
Qualifications & Skills:
5+ years of experience in quality assurance within a food or dietary supplement manufacturing facility.
4+ years in a leadership role, managing quality teams.
FDA and NSF audit experience required.
HACCP certification or the ability to develop HACCP plans.
Proficiency in MS Office, ERP systems, and quality management software.
Strong knowledge of manufacturing processes, process development, and troubleshooting.
BS in Food Science, Microbiology, Chemistry, or a related field preferred.
Strong organizational, leadership, and interpersonal skills.
Ability to manage competing priorities in a fast-paced environment.
Excellent decision-making skills, even in high-pressure situations.
This is an exciting opportunity to lead quality initiatives in a growing dietary supplement manufacturing environment, ensuring compliance, innovation, and operational excellence.