Hybrid Senior Director, Quality Assurance, Regulatory Affairs

at Onnit

• Job title: Senior Director, Quality Assurance, Regulatory Affairs
• Job type: Full Time
• Experience level: Senior
• Salary: $175,000 - $200,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Austin, United States

About the role

• Senior Director of Quality Assurance and Regulatory Affairs at Onnit Labs, leading compliance efforts for dietary supplement products while collaborating across departments.

Responsibilities

• 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.
• Facilitates and organizes training matrix as well as 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 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 and go-to-market strategies.
• Advise executive leadership on quality and regulatory risks and opportunities.

Requirements

• 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

Benefits

• 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