Senior Director, Quality Assurance and Regulatory Affairs

Senior Director, Quality Assurance and Regulatory Affairs

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Onnit is an Austin, TX-based supplement company dedicated to supporting everyday heroes—those who need to be fully present and at their best, not only for themselves but also for their families, friends, and colleagues. As a trusted, serious supplement brand, we provide high‑quality products with clinically studied ingredients designed to unlock a deeper mind‑body connection and enhance both mental and physical performance.

Unlike other supplement brands, Onnit enables strength from within, empowering individuals to operate at their peak every day. Backed by medical professionals, industry experts, and a loyal community, we are rapidly growing while staying true to our mission of total human optimization. Recognized as a Best Place to Work in Austin by the Austin Business Journal, we take pride in fostering a dynamic and purpose‑driven environment—and we'd love for you to be part of it.

The Senior Director, Quality Assurance and Regulatory Affairs will lead the company's quality assurance, quality control, and regulatory compliance efforts for its dietary supplement products. This role is responsible for developing and executing quality systems through the electronic Quality Management System (eQMS), overseeing audits and regulatory inspections, and ensuring adherence to applicable regulations, including 21 CFR Parts 111 and 117. The position will also serve as the primary liaison with regulatory agencies such as the FDA and FTC.

In addition to managing day‑to‑day quality and regulatory functions, this leadership role requires strategic oversight and close collaboration across departments to drive continuous improvement and ensure regulatory readiness.

• Serve as the primary system administrator for the eQMS, managing user roles, permissions, workflows, and system access.
• Manage controlled documents (SOPs, policies, specifications) within the eQMS and oversee document creation, review, approval, version control, and archiving.
• Facilitate and organize training matrix and training documents for employees on SOPs, documents, forms, and GMPs and ensure company‑wide compliance training is up to date.
• Oversee product complaints, including Adverse Event (AE) tracking, investigation, and reporting.
• Log and track non‑conformances, deviations, and CAPA activities; monitor progress to ensure timely completion and effectiveness checks, analyze trends, and elevate recurring issues as necessary.
• Conduct internal audits and support third‑party, FDA, and regulatory inspections.
• Generate and analyze quality KPIs and trends and present quality data for management reviews and continuous improvement initiatives.
• Collaborate with R&D, Product Development, Marketing, Legal, and Operations to support product innovation and go‑to‑market strategies.
• Advise executive leadership on quality and regulatory risks and opportunities.

• Maintain inspection readiness through accurate and up‑to‑date quality records.
• Oversee quality control and quality assurance processes, including finished product release.
• Collaborate with production, R&D, procurement, and regulatory teams to ensure quality objectives are met.

• Develop and deliver training on eQMS usage, GMP, and quality processes to internal users.
• Lead the incident management process, ensuring timely identification, investigation, resolution, and documentation of quality‑related events.
• Strong understanding of FDA regulations (21 CFR Part 111/117) and GMP requirements.
• Proficiency in Microsoft Office; familiarity with data visualization tools a plus.
• Experience with eQMS platforms.
• HACCP, PCQI certifications (optional, but preferred).
• Experience with FDA inspections.

Onnit takes into consideration a wide range of factors that are utilized in making compensation decisions including, but not limited to, skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs.…