Director of Quality
$130,000–$170,000 year
On-siteCarson, California, United States
Job Summary
Director of Quality & Regulatory Affairs leading QA/QC, Regulatory Affairs, and Product Development in a GMP-regulated contract-manufacturing environment. Oversees development and implementation of quality systems, ensures cGMP compliance, leads regulatory audits and customer/third-party inspections, drives continuous improvement, and mentors high-performing teams across QA, QC, Regulatory Affairs, and Formulation. Partners with Manufacturing, Operations, Supply Chain, R&D, and Commercial teams to support business objectives and environmental compliance initiatives. Involves oversight of analytical methods development, laboratory operations, and quality testing programs to ensure high-quality nutritional supplement products.
Required Qualifications
- Bachelor's degree in Chemistry, Biology, Food Science, Pharmaceutical Sciences, or a related scientific discipline
- 10+ years of progressive leadership experience within dietary supplements, nutraceuticals, pharmaceuticals, food, or another regulated manufacturing environment
- Proven expertise in Quality Assurance, Quality Control, Regulatory Affairs, and cGMP compliance
- Strong knowledge of FDA regulations, quality systems, audit management, and risk-based quality approaches
- Experience leading teams in manufacturing environments involving tablets, capsules, powders, or similar dosage forms is highly preferred
- Strong analytical chemistry and laboratory operations background
- Demonstrated success building and improving quality systems, processes, and organizational performance
- Excellent leadership, communication, problem-solving, and stakeholder management skills
- Hands-on quality leader with ability to drive regulatory excellence and cross-functional collaboration
Desired Qualifications
- 10+ years of progressive leadership experience in dietary supplements, nutraceuticals, pharmaceuticals, or regulated manufacturing
- Strong knowledge of FDA regulations, quality systems, audit management, and risk-based quality approaches
- Experience leading QA, QC, Regulatory Affairs, and cross-functional teams in a GMP-regulated manufacturing environment
- Hands-on leadership style with ability to mentor and develop high-performing teams
- Advanced degree preferred (not required) in a related scientific discipline
- Experience with environmental compliance initiatives and regulatory inspections
- Strong analytical chemistry and laboratory operations background
- Experience with formulation development and product development processes in regulated industries
- Excellent communication, stakeholder management, and problem-solving skills
- Ability to establish and monitor KPIs and drive continuous improvement across QA, QC, Regulatory Affairs, and Product Development
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.