The Role We are looking for an experienced Quality Manager to own, lead, and continuously improve our Quality Assurance and Quality Control program. This is a hands-on leadership role. You will manage a small team of quality specialists, drive our regulatory compliance program, and serve as the primary quality authority for the facility. This role reports directly to the COO. If you want ownership, visibility, and the opportunity to build a department the right way, this is the job. What You Will Own Regulatory Compliance Serve as the site's primary cGMP compliance authority under 21 CFR Part 111 Lead and manage all CAPA activities from initiation through closure with documented effectiveness checks Prepare for and lead FDA inspections; draft and execute responses to 483 observations Maintain the QMS (Qualio) — ensuring all events, CAPAs, complaints, and documents are current and closed on time Raw Material and Supplier Quality Own the supplier qualification and periodic requalification program Review and approve raw material specifications (RMS); ensure COAs cover all required parameters before release Oversee incoming raw material testing and release decisions Analytical Methods and Laboratory Supervise FTIR identity testing program, including method development, reference standard qualification, and GLP documentation Ensure all analytical methods are scientifically valid, documented, and defensible Oversee OOS/OOT investigation process Complaint Management Drive timely investigation and closure of all customer complaint events per SOP and regulatory requirements Identify systemic trends and initiate CAPAs where warranted Team Leadership and Development Directly manage 2-3 quality specialists Develop team members through structured training, delegation, and coaching Build a department culture of ownership, documentation discipline, and continuous improvement Documentation and Systems Maintain batch record review and approval process Oversee SOP authorship, review cycle, and training compliance Ensure GLP standards are met across all laboratory and quality activities What We Are Looking For Required 5+ years of quality experience in dietary supplement, pharmaceutical, or food manufacturing Minimum 2 years in a quality leadership or supervisory role Deep working knowledge of 21 CFR Part 111 (cGMP for dietary supplements) Hands-on experience managing CAPAs, responding to FDA inspections, and writing 483 responses Experience with supplier qualification programs and raw material specification management Familiarity with FTIR or other spectroscopic identity testing methods Experience managing a QMS platform (Qualio, MasterControl, TrackWise, or similar) Strong technical writing and documentation skills Bachelor's degree in Chemistry, Food Science, Biology, or a related field Strongly Preferred Experience with liposomal, emulsion, or liquid dietary supplement manufacturing NSF, USP, or Informed Sport facility experience Familiarity with HPTLC, ICP-MS, or contract laboratory management Experience building or overhauling a quality program (not just maintaining one) What Success Looks Like in Year One All open CAPAs closed with documented evidence of effectiveness Supplier qualification program fully current for all active vendors FTIR reference standards re-qualified with third-party confirmatory testing Complaint events closed within SOP timelines — zero events >30 days overdue Quality team trained, developing, and operating independently on routine release decisions Zero repeat observations in any FDA interaction Why Virun Direct access to senior leadership — you will not be buried in a corporate structure Real scope and ownership from day one Growing company with meaningful investment in quality infrastructure Innovative product formats that require genuine technical quality expertise Competitive salary, benefits, and a team that takes the work seriously

Pay:

$64,000.00 - $95,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person