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Hims & Hers, a leading telehealth and wellness platform (NYSE: HIMS), is seeking a Quality Compliance Specialist to manage post-market surveillance and complaint handling for prescription products. This role sits at the intersection of quality, compliance, and customer experience, working with pharmacy partners and medical teams to ensure complaints are investigated thoroughly, documented accurately, and resolved within regulatory and contractual timelines.
You will independently manage the full lifecycle of customer and partner complaints: intake, triage, investigation oversight, and resolution. Key responsibilities include reviewing complaint details for accuracy and proper attribution, routing complaints to appropriate third-party pharmacies, and evaluating the adequacy of pharmacy partners' root cause analyses. You will determine regulatory reportability under 503A/503B classification and applicable FDA requirements, exercising judgment in ambiguous cases. You'll track complaint deadlines against contractual and regulatory timelines, escalating at-risk cases proactively to leadership.
You will identify and analyze complaint trends across categories (packaging, cold chain, dosage), distinguish true increases from noise, and recommend process improvements. You'll own creation of regular metric reports for senior leadership covering trends, root causes, and action plans. This role includes authority to review third-party investigation findings and determine complaint outcomes without case-by-case director approval. You'll organize and lead cross-functional meetings with customer experience, pharmacy operations, R&D quality, medical affairs, and strategic quality teams to implement resolutions.
The role preferably requires EST time zone alignment with third-party pharmacy partners. You'll work in a fast-paced, remote-friendly healthcare environment managing multiple open investigations simultaneously while maintaining rigorous documentation accuracy.
REQUIREMENTS:
- Active Pharmacy Technician or Pharmacist license (preferred)
- Bachelor's degree in relevant science, quality, or engineering field (preferred); Associate degree with equivalent experience considered
- 4+ years of experience in pharmacy operations, quality assurance, or complaint handling in a regulated environment
- Familiarity with 503A/503B compounding pharmacy regulations and FDA reporting requirements (21 CFR Parts 210/211, cGMP, GDP practices)
- Understanding of USP <795> and <800> standards and non-sterile compounding processes
- Strong oral and written communication skills; comfortable drafting formal correspondence
- Experience with complaint or case management platforms (Zendesk or similar)
- Ability to manage multiple open investigations simultaneously with documentation accuracy
- Excellent analytical skills to identify trends and root causes in complaint data
- Organizational skills to manage multiple tasks simultaneously and meet deadlines
- High sense of accountability and collaborative, team-oriented mindset
- Commitment to patient safety and rigorous quality standards
