Job Details

About Supergut

Supergut is redefining the human health trajectory - from the inside out. Backed by clinical science and powered by prebiotic fiber, our products are designed to improve gut health, balance blood sugar, and support metabolic and hormonal wellness. It's often said that the gut is your second brain and wellness starts in your digestive tract. As a mission-driven health and wellness brand, we're building community through meaningful experiences, operational excellence, and culture-shaping storytelling.About the Role

Supergut is seeking a Quality & Regulatory Systems Manager to build, own, and maintain the quality and regulatory infrastructure that supports our growing dietary supplement portfolio and ensures long-term compliance in a complex regulatory environment.
This is a brand-side functional leadership role responsible for overseeing compliance with FDA dietary supplement regulations (21 CFR 111), interpreting and applying regulatory requirements to internal systems, managing quality operations across contract manufacturing partners, maintaining third-party certifications, and safeguarding product integrity. The role centers on documentation, regulatory alignment, finished product release oversight, retain management, supplier qualification, and risk mitigation.Key ResponsibilitiesQuality Management System (QMS) Ownership:

• Develop, implement, and continuously improve Supergut's internal Quality Management System
• Create and maintain:
  • Raw material specifications
  • Finished product specifications
  • Packaging component specifications
  • SOPs and quality manuals
• Maintain document control processes, revision tracking, and controlled documentation systems
• Establish and manage change control procedures
• Ensure quality systems always remain audit-ready

Current Good Manufacturing Process (cGMP) Compliance (21 CFR 111):

• Ensure Supergut maintains compliance with dietary supplement cGMP requirements under 21 CFR 111
• Establish and oversee finished product testing and release processes
• Review and approve:
  • Certificates of Analysis (COAs)
  • Analytical testing reports
  • Batch documentation for release verification
• Maintain traceability systems and release documentation
• Ensure appropriate documentation retention practices are followed

Finished Product Retain Management:

• Establish and oversee a compliant finished product retain program
• Ensure retains are collected from contract manufacturers in accordance with regulatory requirements
• Maintain secure, organized storage of retains (or oversee third-party retain storage facilities)
• Track retain inventory and expiration timelines
• Conduct periodic organoleptic evaluations of retains as part of ongoing quality monitoring
• Support investigations, complaints, or recall activities using retain samples when needed

Contract Manufacturer & Supplier Oversight:

• Qualify and approve contract manufacturers, raw material suppliers, and third-party testing laboratories
• Establish and maintain supplier qualification programs (risk-based; primarily paper audits with on-site visits as needed)
• Review and manage quality agreements
• Conduct supplier performance evaluations
• Travel up to 10-20% as required for audits or facility visits

Regulatory & Certification Management:

• Manage and maintain third-party certifications, including but not limited to:
  • Project Non-GMO
  • Low FODMAP
  • Vegan, Gluten Free or other applicable certifications
• Prepare and submit certification documentation and renewals
• Oversee retailer compliance submissions and regulatory documentation
• Maintain structure/function claim substantiation files
• Support regulatory inspections or inquiries as needed

Testing & Stability Program Oversight:

• Oversee analytical testing programs with contract manufacturers and third-party laboratories
• Develop and maintain product-specific stability protocols
• Establish and manage a long-term stability program
• Monitor and document ongoing stability results to ensure label claim compliance throughout shelf life

Regulatory & Claims Compliance Oversight:

• Maintain and organize approved structure/function claim substantiation files to ensure documentation is complete and audit-ready
• Review marketing materials, packaging, website copy, and external communications to ensure all claims align with approved substantiation and regulatory requirements
• Partner with Product Development and external legal counsel (as applicable) to ensure regulatory alignment of claims prior to product launch
• Monitor evolving regulatory guidance to identify potential risk areas in claims or labeling
• Serve as the internal compliance checkpoint for outward-facing product messaging

Risk Management & Consumer Protection:

• Lead investigations of deviations, non-conformances, complaints, and adverse events
• Conduct root cause analyses and manage corrective and preventive actions (CAPA)
• Develop and execute mock recall procedures and maintain recall readiness systems

Cross-Functional Collaboration:

• Partner with Product Development to ensure specifications align with approved formulations
• Collaborate with Supply Chain on supplier onboarding, raw material changes, and risk assessment
• Work with Product Development and external legal partners to review structure/function claims for regulatory alignment and documentation completeness
• Provide quality and regulatory updates to leadership as needed

Qualifications

• 5+ year's experience in Quality Assurance and/or Regulatory Affairs within dietary supplements
• Strong working knowledge of FDA dietary supplement regulations (21 CFR 111)
• Demonstrated experience managing third-party certification programs (e.g., Non-GMO Project, Vegan, Low FODMAP or similar)
• Experience overseeing finished product testing and release processes
• Experience developing and maintaining stability programs
• Experience managing retain programs for finished dietary supplement products
• Experience managing quality systems across multiple contract manufacturers
• Familiarity with analytical testing methods and third-party lab coordination
• Preferred: Experience with WERCSmart or similar retailer compliance submission platforms
• Bachelor's degree in Food Science, Chemistry, Biology, or related field
• Highly organized with strong documentation and systems-building skills
• Ability to operate independently in a remote-first, fast-paced environment

Why You'll Love Working at Supergut

• 100% remote-first team with flexible work hours.
• Mission-driven company making a real difference in people's health.
• Collaborative, fast-moving environment with room to innovate.
• Competitive compensation, medical, dental, and vision benefits, matching 401K and monthly wellness stipend
• The chance to help grow a purpose-led brand from the ground up.

Compensation
This position has an expected salary range of $110,000 - $120,000.
Supergut is an equal opportunity employer. We welcome applications from all backgrounds and employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or any other dimension of diversity.

****Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa currently.