Director of Quality

Kalon Executive Search•Carson, CA

51d•Onsite

About The Position

Kalon Executive Search is partnering with a leading contract manufacturing organization in the nutritional supplement industry to identify a highly accomplished Director of Quality & Regulatory Affairs. This is a key leadership opportunity for an experienced quality professional who thrives in a fast-paced, GMP-regulated manufacturing environment and is passionate about building best-in-class quality systems. The Director of Quality & Regulatory Affairs will provide strategic and operational leadership across Quality Assurance, Quality Control, Regulatory Affairs, and Product Development functions. This executive will play a critical role in ensuring regulatory compliance, driving continuous improvement initiatives, maintaining audit readiness, and supporting the successful development and commercialization of high-quality nutritional supplement products. This is an in-person position located in Carson, CA.

Requirements

Bachelor's degree in Chemistry, Biology, Food Science, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
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.

Nice To Haves

Advanced degree preferred.

Responsibilities

Lead and oversee Quality Assurance, Quality Control, Regulatory Affairs, and Formulation teams.
Ensure compliance with cGMP regulations, FDA requirements, customer standards, and industry best practices.
Develop, implement, and continuously improve quality systems, policies, procedures, and documentation.
Direct investigations related to nonconformances, deviations, CAPAs, customer complaints, and quality events.
Maintain inspection readiness and serve as a key leader during customer, regulatory, and third-party audits.
Establish and monitor key quality metrics and KPIs to drive operational excellence and continuous improvement.
Provide technical and regulatory guidance to internal teams and external customers.
Partner cross-functionally with Manufacturing, Operations, Supply Chain, R&D, and Commercial teams to support business objectives.
Oversee environmental compliance initiatives and ensure adherence to applicable regulations.
Support analytical methods development, laboratory operations, and quality testing programs.
Mentor, develop, and lead high-performing quality and regulatory teams.