Quality Control Manager

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.

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.

• 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

• 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

• 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

• 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

• 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

• 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

• 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…