Our client — a leading manufacturer in the nutraceutical and dietary supplement industry — is seeking an experienced Vice President of Quality & Regulatory Affairs to oversee all aspects of Quality Assurance, Quality Control, and Regulatory Compliance across multiple manufacturing and packaging facilities.

The ideal candidate is a hands-on, strategic leader who combines technical expertise in FDA-regulated manufacturing with proven experience leading high-performing teams, implementing GMP systems, and ensuring product integrity across global markets.

Key Responsibilities

• Lead and direct all Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs (RA) functions for the organization.

• Develop, implement, and manage a comprehensive Quality Management System (QMS) aligned with FDA, NSF, TGA, and ISO standards.

• Oversee cGMP compliance, documentation, audits, validations, and continuous improvement initiatives.

• Serve as the company’s primary liaison with FDA, NSF, and other regulatory agencies during inspections and audits.

• Manage CAPA programs, supplier qualification, and internal audit systems to ensure consistent manufacturing performance.

• Oversee regulatory submissions, including labeling, claims substantiation, product registration, and international documentation.

• Collaborate cross-functionally with R&D, Operations, Supply Chain, and Marketing to ensure new product development aligns with compliance and quality standards.

• Build, mentor, and lead multi-site QA/QC and Regulatory teams to achieve operational excellence and continuous improvement.

• Develop and monitor department KPIs, ensuring accountability and performance across all quality functions.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Engineering, or related scientific discipline (Master’s preferred).

• Minimum of 15 years of progressive experience in Quality and Regulatory leadership within nutraceuticals, dietary supplements, food, or pharmaceutical manufacturing.

• Strong knowledge of 21 CFR Parts 111, 117, 101, 210/211, and ISO 9001.

• Demonstrated success managing FDA and third-party audits with a record of zero major observations.

• Proven experience building and managing multi-site teams and implementing scalable QMS frameworks.

• Excellent communication and leadership skills with the ability to influence at all organizational levels.

• ASQ Certification (CQA, CQE, or CMQ/OE) strongly preferred.

Why Join

• Opportunity to lead a best-in-class Quality & Regulatory organization in a rapidly growing nutraceutical company.

• Strategic executive role with influence over product quality, safety, and innovation.

• Collaborative culture that values science, transparency, and continuous improvement.

• Competitive compensation, benefits, and long-term growth potential.