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Manager, Quality Assurance – Regulatory

Remote · USA Full-time New today

Job Description:

  • Lead product testing programs for all new product launches, including stability, compatibility, packaging validation, AQL inspections, and production surveillance testing.
  • Establish and maintain AQL standards and support factories in meeting Starface requirements.
  • Review, approve, and monitor COAs, test reports, batch records, and release documentation.
  • Support packaging development and engineering, advising on technical requirements, specifications, test parameters, and risk considerations (cosmetic packaging preferred).
  • Partner with PD and Packaging to validate component design, functionality, material compatibility, and manufacturability.
  • Oversee packaging testing requirements (drop tests, leakage, transit testing, seal integrity, etc.) and ensure successful qualification before commercial production.
  • Manage supplier quality programs, including onboarding, qualification, and ongoing performance evaluation of manufacturers, fillers, and material suppliers.
  • Coordinate and/or conduct third-party audits and assessments; track findings, corrective actions, and follow-up.
  • Establish and maintain supplier scorecards and develop corrective action plans as needed.
  • Lead non-conformance investigations, root-cause analysis, and CAPA activities to drive sustainable improvements across suppliers and internal teams.
  • Maintain and enhance systems for quality metrics, deviation tracking, risk assessments, and continuous improvement programs.
  • Identify trends and develop proactive strategies to prevent quality issues before they arise.
  • Oversee complaints intake, review, categorization, trending, and reporting, partnering with CX to ensure timely and meaningful responses.
  • Lead regulatory and quality review of escalation cases and manage adverse event reporting processes.
  • Translate consumer insights into actionable product or process improvements.
  • Maintain up-to-date product registrations, including MoCRA compliance, OTC drug listings, and medical device establishment and product listings.
  • Support ingredient, label, and claims reviews, ensuring compliance with domestic and international regulations.
  • Review and approve packaging, artwork, and label copy for regulatory accuracy.
  • Partner with external regulatory agencies, consultants, suppliers, and retailers as needed for filings and documentation (ILs, SDS, COAs, certifications, etc.).
  • Provide training and updates to internal teams on relevant regulatory changes (MoCRA, Prop 65, global cosmetics regulations, etc.).
  • Serve as a regulatory representative in cross-functional meetings, offering insights related to compliance, risk mitigation, and technical guidance.

Requirements:

  • You hold a BS in a scientific field (Chemistry, Biology, Engineering) or equivalent experience
  • You have 4+ years of experience in quality assurance and/or regulatory roles within cosmetics, OTC, or medical device environments
  • You have strong experience and a deep understanding of technical packaging validation and testing processes
  • You have experience with QMS systems (document control, SOPs, change control)
  • You have experience with product testing (stability, compatibility, AQL, surveillance)
  • You have strong working experience in supplier quality, audits, and compliance management
  • You have non-conformance investigations, CAPA, root-cause analysis experience
  • You have experience working with ERPs (Netsuite ideal but not required)
  • You have supported complaints handling, trending, and adverse event reporting
  • You’re highly organized, detail-oriented, and effective at balancing accuracy with fast timelines
  • You excel in cross-functional project management and transparent communication
  • You’re proactive, curious, and entrepreneurial—anticipating needs and preparing for challenges before they arise
  • Can translate complex quality and regulatory requirements into clear, actionable guidance

Benefits:

  • Access to high-quality health care options
  • Access to a 401k with 5% employer match eligibility
  • 4 weeks of vacation plus up to 20 paid holidays
  • 12 weeks fully paid parental leave
  • + 5 days of pet-ernity leave for pet adoption
  • Home office & internet supplement stipend
  • Fully remote work environment
  • ...and much, much more!

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