Quality & Regulatory Systems ManagerSupergut 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.Quality Management System (QMS) Ownership:Develop, implement, and continuously improve Supergut's internal Quality Management SystemCreate and maintain: Raw material specificationsFinished product specificationsPackaging component specificationsSOPs and quality manualsMaintain document control processes, revision tracking, and controlled documentation systemsEstablish and manage change control proceduresEnsure quality systems always remain audit-readyCurrent Good Manufacturing Process (cGMP) Compliance (21 CFR 111):Ensure Supergut maintains compliance with dietary supplement cGMP requirements under 21 CFR 111Establish and oversee finished product testing and release processesReview and approve: Certificates of Analysis (COAs)Analytical testing reportsBatch documentation for release verificationMaintain traceability systems and release documentationEnsure appropriate documentation retention practices are followedFinished Product Retain Management:Establish and oversee a compliant finished product retain programEnsure retains are collected from contract manufacturers in accordance with regulatory requirementsMaintain secure, organized storage of retains (or oversee third-party retain storage facilities)Track retain inventory and expiration timelinesConduct periodic organoleptic evaluations of retains as part of ongoing quality monitoringSupport investigations, complaints, or recall activities using retain samples when neededContract Manufacturer & Supplier Oversight:Qualify and approve contract manufacturers, raw material suppliers, and third-party testing laboratoriesEstablish and maintain supplier qualification programs (risk-based; primarily paper audits with on-site visits as needed)Review and manage quality agreementsConduct supplier performance evaluationsTravel up to 10–20% as required for audits or facility visitsRegulatory & Certification Management:Manage and maintain third-party certifications, including but not limited to: Project Non-GMOLow FODMAPVegan, Gluten Free or other applicable certificationsPrepare and submit certification documentation and renewalsOversee retailer compliance submissions and regulatory documentationMaintain structure/function claim substantiation filesSupport regulatory inspections or inquiries as neededTesting & Stability Program Oversight:Oversee analytical testing programs with contract manufacturers and third-party laboratoriesDevelop and maintain product-specific stability protocolsEstablish and manage a long-term stability programMonitor and document ongoing stability results to ensure label claim compliance throughout shelf lifeRegulatory & Claims Compliance Oversight:Maintain and organize approved structure/function claim substantiation files to ensure documentation is complete and audit-readyReview marketing materials, packaging, website copy, and external communications to ensure all claims align with approved substantiation and regulatory requirementsPartner with Product Development and external legal counsel (as applicable) to ensure regulatory alignment of claims prior to product launchMonitor evolving regulatory guidance to identify potential risk areas in claims or labelingServe as the internal compliance checkpoint for outward-facing product messagingRisk Management & Consumer Protection:Lead investigations of deviations, non-conformances, complaints, and adverse eventsConduct root cause analyses and manage corrective and preventive actions (CAPA)Develop and execute mock recall procedures and maintain recall readiness systemsCross-Functional Collaboration:Partner with Product Development to ensure specifications align with approved formulationsCollaborate with Supply Chain on supplier onboarding, raw material changes, and risk assessmentWork with Product Development and external legal partners to review structure/function claims for regulatory alignment and documentation completenessProvide quality and regulatory updates to leadership as neededQualifications5+ year's experience in Quality Assurance and/or Regulatory Affairs within dietary supplementsStrong 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 processesExperience developing and maintaining stability programsExperience managing retain programs for finished dietary supplement productsExperience managing quality systems across multiple contract manufacturersFamiliarity with analytical testing methods and third-party lab coordinationPreferred: Experience with WERCSmart or similar retailer compliance submission platformsBachelor's degree in Food Science, Chemistry, Biology, or related fieldHighly organized with strong documentation and systems-building skillsAbility to operate independently in a remote-first, fast-paced environmentWhy You'll Love Working at Supergut100% 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 stipendThe chance to help grow a purpose-led brand from the ground up.CompensationThis 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.