СШАQuality Compliance Specialist , Post Market Surveillance
1 мес. назад
90k–115k USD / годСШАRemote
quality managementcompliancepost market surveillanceinvestigationdocumentation
Manage intake, investigation, and resolution of complaints related to prescription products ensuring regulatory compliance and customer satisfaction.
Обязанности
- We're looking for a detail-oriented Quality Compliance Specialist to manage the intake, investigation, and resolution of customer and partner complaints related to prescription products. This role sits at the intersection of quality, compliance, and customer experience, working closely with pharmacy partners, and medical teams, to ensure complaints are investigated thoroughly, documented accurately, and closed within regulatory and contractual timelines. This role requires a hands-on, detail-oriented and highly organized individual with a strong background in pharmaceutical and/or pharmacy customer complaint management, and trending of customer data in order to drive continuous improvement. This individual will support third party partners in investigation of product-related complaints, —ensuring the highest standards of customer satisfaction, regulatory compliance, and operational excellence.
- Preferably work in the EST time zone in order toe nsure alignment with Hims third party pharmacy partners
- Independently ensure customer complaints are thoroughly investigated, documented, and communicated in a timely and transparent manner to customers and relevant stakeholders exercising judgement on complaint disposition
- 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, independently assessing the adequacy of root cause analysis submitted and requiring 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 or novel cases not directly addressed by the procedure
- Hold third party pharmacies accountable for complaint closure summaries and investigation reports per contractual agreements with counterparties
- Track complaint deadlines against contractual and regulatory reporting deadlines and determine the need for escalating at-risk cases proactively in the right pathway to leadership
- Identify and analyze complaint trends across complaint categories (e.g., packaging, cold chain, dosage), distinguish true complaints increase and recommend process changes based on findings.
- Own the creation of regular metric reports for presentation to 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
- This role has the authority to review and provide concurrence on third-party complaint investigation findings, and determine complaint investigation outcome without requiring case-by-case approval from the Director.
Требования
- 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 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.
Условия
- 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
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
- Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
- It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
- To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement .
Другое
- Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.
- Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit and. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit.