• 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 systemaccess
• Manage controlled documents (SOPs, policies, specifications) within the eQMS and oversee document creation,review, approval, version control, and archiving
• Facilitates and organizes training matrix as well as training documents for employees on SOPs, documents, forms andGMPs 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 andeffectiveness checks, analyze trends, and escalate 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 andgo-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
• Lead the incident management process, ensuring timely identification, investigation, resolution, and documentation ofquality-related events

• Develop and deliver training on eQMS usage, GMP, and quality processes to internal users
• Strong understanding of FDA regulations (21 CFR Part 111/117) and GMP requirements
• Experience with eQMS platforms
• Experience with FDA inspections
• Advise executive leadership on quality and regulatory risks and opportunities

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

• This position is bonus eligible and employees are eligible to participate in our benefits plan

Should the employee choose to participate, they can choose from a range of benefits to include, but is not limited to, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, sick leave, paid vacation and holidays

• Any coverages for health insurance will be in accordance with the terms and conditions of the applicable plans and associated governing plan documents

USA Pay Range $175,000—$200,000 USD

• Full medical, dental, and vision benefits
• Basic Life Insurance
• Immediate 401(k) eligibility with company matching
• Unlimited vacation
• Paid holidays

Flexible workplace policy $100/month flexible benefit stipend

• Tuition reimbursement
• Fringe benefits include in-office meals, product credits and discounts, lifestyle spending account, family planning, online learning, fitness stipend, among many others