Senior Director, Quality Assurance and Regulatory Affairs

Austin, TX - USA

Monthly Salary: $ 175000 - 200000

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

About Onnit:

Onnit is an Austin TX-based supplement company dedicated to supporting everyday heroesthose 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 environmentand wed love for you to be part of it.

JOB SUMMARY

The Senior Director Quality Assurance and Regulatory Affairs will lead the companys 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 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.

KEY 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.

ADDITIONAL RESPONSIBILITIES

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.

QUALIFICATIONS

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. 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

$175000 - $200000 USD

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

EOE race/color/religion/sex/sexual orientation/gender identity/national origin/disability/veteran status

Required Experience:

Exec

About Onnit:Onnit is an Austin TX-based supplement company dedicated to supporting everyday heroesthose 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 wi...