Quality Compliance Specialist , Post Market Surveillance

hims & hers
United States
Workplace: RemoteFull timeUSD 90,000 - 115,000 annuallyFunction: Legal, Risk & ComplianceExperience: 4+ yearsEducation: bachelorsSkills: ["Communication","Organization","Accountability","Analytical skills","Collaboration"]

Manage intake, investigation, and resolution of customer and partner complaints related to prescription products, ensuring thorough documentation and closure within regulatory and contractual timelines. Work with pharmacy partners and medical teams to triage complaints, evaluate root-cause adequacy, determine regulatory reportability (503A/503B, FDA requirements), and track deadlines. Produce metrics for senior leadership and lead cross-functional escalations to drive corrective and preventive improvements.

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FursaFursa
hims & hers
hims & hers
13 hours ago

Quality Compliance Specialist , Post Market Surveillance

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Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 2 hours agoStatus: Live

Job Summary

Manage intake, investigation, and resolution of customer and partner complaints related to prescription products, ensuring thorough documentation and closure within regulatory and contractual timelines. Work with pharmacy partners and medical teams to triage complaints, evaluate root-cause adequacy, determine regulatory reportability (503A/503B, FDA requirements), and track deadlines. Produce metrics for senior leadership and lead cross-functional escalations to drive corrective and preventive improvements.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Legal, Risk & Compliance
Seniority: Mid level

Key Responsibilities

  • •Ensure customer complaints are thoroughly investigated, documented, and communicated to customers and stakeholders in a timely, transparent manner.
  • •Review complaint details for accuracy and correct linkage of order IDs and pharmacy/compounder attribution; triage and route complaints to the appropriate third parties.
  • •Evaluate third-party pharmacy partners’ investigations, assess root-cause analysis adequacy, and require re-investigation when findings don’t meet quality standards.
  • •Determine regulatory reportability of complaint events under 503A/503B classification and applicable FDA reporting requirements, exercising judgment in ambiguous cases.
  • •Track complaint deadlines against regulatory and contractual timelines, create recurring metric reports for senior leadership, and organize cross-functional meetings to implement resolutions.

Pay and Benefits

Salary: USD 90,000 - 115,000 annually
Equity and Bonus:Equity
Perks:Paid LeaveHealth InsuranceDentalVisionParental Leave401kEquity

Key Requirements

  • •Active Pharmacy Technician or Pharmacist license (preferred).
  • •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).
  • •Understanding USP standards and non-sterile compounding processes.
  • •Experience with complaint or case management platforms (e.g., Zendesk) and strong oral/written communication for drafting correspondence.
Experience:4+ yearsPharmaceuticalsHealthcareRegulated environment
Education:Bachelor's in science, quality, or engineering
Skills:CommunicationOrganizationAccountabilityAnalytical skillsCollaboration
Licenses:Pharmacy Technician licensePharmacist license
Tech Stack:Zendesk

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
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