Quality Compliance Specialist , Post Market Surveillance

Hims & Hers • ,

3d • $90,000 - $115,000 • Remote

About The Position

Hims & Hers is seeking a detail-oriented Quality Compliance Specialist to manage the intake, investigation, and resolution of customer and partner complaints related to prescription products. This role is crucial at the intersection of quality, compliance, and customer experience. The specialist will collaborate closely with pharmacy partners and medical teams to ensure complaints are thoroughly investigated, accurately documented, and resolved within regulatory and contractual timelines. The ideal candidate is hands-on, highly organized, and possesses a strong background in pharmaceutical/pharmacy customer complaint management and data trending to drive continuous improvement. This role supports third-party partners in investigating product-related complaints, upholding high standards of customer satisfaction, regulatory compliance, and operational excellence.

Requirements

• Active Pharmacy Technician or Pharmacist license preferred.
• Bachelor’s degree preferred in a relevant science, quality, or engineering field; or an associate degree with equivalent experience will be 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, and GDP practices.
• Understanding USP <795> and <800> standards and non-sterile compounding processes.
• Strong oral and written communication skills — comfortable drafting formal correspondence to partners and internal stakeholders.
• Experience with complaint or case management platforms (Zendesk, or similar).
• Ability to manage multiple open investigations simultaneously while maintaining documentation accuracy.
• Excellent analytical skills to identify trends and root causes across complaint data.
• Comfortable organizational skills with the ability to manage multiple tasks simultaneously to meet deadlines and working cross-functionally in a fast-paced, remote-friendly healthcare environment.
• High sense of accountability and a collaborative, team-oriented mindset.
• Commitment to patient safety and rigorous quality standards.
• Use pharmacy expertise to influence workflow changes and product improvements related to customer safety and satisfaction.

Nice To Haves

• Preferably work in the EST time zone in order to ensure alignment with Hims third party pharmacy partners.

Responsibilities

• Manage the intake, investigation, and resolution of customer and partner complaints related to prescription products.
• Ensure customer complaints are thoroughly investigated, documented, and communicated in a timely and transparent manner to customers and relevant stakeholders.
• Review complaint details for accuracy, ensuring proper linkage of order IDs, and pharmacy/compounder attribution.
• Triage and route complaints to the appropriate third parties based on complaint description and compounding/dispensing location.
• Evaluate third-party pharmacy partners' complaints investigations, assessing the adequacy of root cause analysis and requiring re-investigation when findings do not meet quality standards.
• Determine regulatory reportability of complaint events under 503A/503B classification and applicable FDA reporting requirements.
• Hold third party pharmacies accountable for complaint closure summaries and investigation reports per contractual agreements.
• Track complaint deadlines against contractual and regulatory reporting deadlines and escalate at-risk cases proactively.
• Identify and analyze complaint trends across complaint categories (e.g., packaging, cold chain, dosage) and recommend process changes.
• Create regular metric reports for senior leadership covering complaint trends, root cause analysis, and action plans.
• Organize and lead cross-functional business meetings with customer experience, pharmacy operations, R&D quality, medical affairs, supplier and strategic quality for complaint escalation to implement resolution.
• Review and provide concurrence on third-party complaint investigation findings, and determine complaint investigation outcome without requiring case-by-case approval from the Director.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level