Vice President, Quality Assurance & Regulatory Affairs
USFull-TimeVp
Salary248,220 - 303,380 USD per year
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Job Details
- Experience
- 15–20+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs
- Required Skills
- Quality AssuranceRisk Management
Requirements
- 15–20+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs within FDA-regulated industries (dietary supplements required).
- Bachelor’s degree in Chemistry, Biology, Food Science, or related scientific field; advanced degree strongly preferred.
- Deep expertise in GMP regulations, including 21 CFR Parts 101, 110, 111, and 117.
- Proven experience in dietary supplement manufacturing environments, including gummy product quality operations.
- Strong background in regulatory review processes including ingredients, labeling, claims, and certifications.
- Demonstrated success leading QA/RA teams and influencing cross-functional stakeholders at executive level.
- Hands-on experience managing audits, inspections, and regulatory agency interactions.
- Strong knowledge of CAPA systems, risk management, and root cause analysis methodologies.
- Exceptional communication, leadership, and organizational influence skills.
- Ability to operate effectively in a fast-paced, innovation-driven environment.
Responsibilities
- Lead the global Quality Assurance & Regulatory Affairs strategy, ensuring alignment with business growth objectives and regulatory requirements.
- Oversee development and execution of Quality Management Systems in compliance with FDA regulations (including 21 CFR Parts 101, 110, 111, and 117) and industry best practices.
- Ensure full regulatory compliance for existing and new products, including ingredient reviews, labeling, claims substantiation, certifications, and marketing materials.
- Provide executive leadership during regulatory inspections, audits, and external authority interactions.
- Partner with Product, Supply Chain, and cross-functional teams to ensure end-to-end compliance and timely product delivery.
- Build, scale, and mentor high-performing QA/RA teams, fostering a strong culture of quality and accountability.
- Lead supplier qualification and monitoring programs, including quality agreements and risk assessments.
- Drive continuous improvement initiatives using data, metrics, root cause analysis, and CAPA systems.
- Stay current on evolving regulatory landscapes and proactively recommend compliance strategies.
- Participate in external advocacy and policy discussions impacting the dietary supplement industry.
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