2 дня назад
Quality Compliance Specialist (Pharmacy)
90 000 - 115 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Compliance Specialist (Pharmacy): Managing investigations and resolutions for prescription-product complaints in a US-remote healthcare platform with an accent on pharmacy partner oversight, regulatory reporting, and complaint documentation. Focus on evaluating root cause analyses, determining 503A/503B and FDA reportability, tracking contractual deadlines, and analyzing complaint trends to improve patient safety and operations.
Location: US Remote; preferably aligned with the EST time zone to support pharmacy partner collaboration.
Salary: $90,000–$115,000 per year for US-based candidates; candidates outside the US receive a location-specific range from the recruiter.
Company
Hims & Hers is a public health and wellness platform providing personalized access to diagnosis, treatment, and prescription delivery.
What you will do
- Manage the intake, investigation, documentation, communication, and closure of customer and partner complaints related to prescription products.
- Review complaint accuracy, order and pharmacy attribution, triage cases, and route them to the appropriate pharmacy or compounding partner.
- Evaluate third-party investigations, assess root cause analyses, request re-investigations when needed, and determine complaint outcomes.
- Determine regulatory reportability under 503A/503B classifications and applicable FDA requirements.
- Track contractual and regulatory deadlines, escalate at-risk cases, and hold pharmacy partners accountable for complete investigation reports.
- Analyze complaint trends, prepare metrics for senior leadership, and lead cross-functional meetings focused on corrective actions and product improvements.
Requirements
- 4+ years of experience in pharmacy operations, quality assurance, or complaint handling in a regulated environment.
- Knowledge of 503A/503B compounding pharmacy regulations, FDA reporting requirements, 21 CFR Parts 210/211, cGMP, and GDP practices.
- Understanding of USP 795 and USP 800 standards and non-sterile compounding processes.
- Strong written and oral communication, analytical skills, documentation discipline, and the ability to manage multiple investigations simultaneously.
- Experience with complaint or case management platforms such as Zendesk.
- Active Pharmacy Technician or Pharmacist license preferred; a relevant bachelor's degree or an associate degree with equivalent experience is preferred.
Culture & Benefits
- Remote-friendly work environment with an EST time zone preference for partner alignment.
- Competitive salary and equity compensation for full-time roles.
- Unlimited PTO, company holidays, and quarterly mental health days.
- Medical, dental, vision, and parental leave benefits.
- Employee Stock Purchase Program and 401(k) with employer matching.
- Offsite team retreats and a workplace focused on ethics, wellness, inclusion, and belonging.
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