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ONNIT · 2 months ago

Senior Director, Quality Assurance and Regulatory Affairs

Austin, TX - Hybrid

Full-time

Hybrid

Director/Executive

Onnit is an Austin-based supplement company dedicated to supporting everyday heroes. The Senior Director, Quality Assurance and Regulatory Affairs will lead the company's quality assurance and regulatory compliance efforts for dietary supplement products, overseeing audits, inspections, and ensuring adherence to applicable regulations.

Consumer GoodsDietary SupplementsE-CommerceFitnessFood and BeverageHealth CareSubscription Service

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

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

Qualification

EQMS managementFDA regulationsGMP requirementsHACCP certificationPCQI certificationData visualization toolsMicrosoft OfficeTraining developmentIncident managementQuality control

Required

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

Experience with FDA inspections

Preferred

HACCP, PCQI certifications (optional, but preferred)

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