Quality Compliance Specialist, Post Market Surveillance

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $90k - $115k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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hims & hers

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

🏥 Healthcare

💼 Consulting

📣 Marketing

Healthcare • Consulting • Marketing

Hims & Hers is an online platform with over 1 million subscribers that connects patients to licensed healthcare professionals across all 50 states in the U. S. The service offers comprehensive support for sexual health, weight loss, hair regrowth, mental health, and skincare through a 100% online process. Clients can receive personalized treatment plans which may include prescription medications, and benefit from free and discreet shipping. Hims & Hers prides itself on providing accessible and affordable healthcare without the need for insurance, offering transparent pricing and support from licensed providers. It aims to empower individuals by making healthcare and treatment conveniently available on their own terms, including mental health support, which includes treatments for anxiety and depression.

📋 Description

• Manage intake, investigation, and resolution of customer and partner complaints related to prescription products • Independently investigate, document, and communicate complaints to customers and relevant stakeholders • Review complaint details for accuracy, including order IDs and pharmacy/compounder attribution • Triage and route complaints to appropriate third parties based on complaint description and location • Evaluate third-party pharmacy investigations and assess root cause analysis adequacy • Require re-investigation when findings do not meet quality standards • Determine regulatory reportability under 503A/503B classifications and applicable FDA reporting requirements • Hold third-party pharmacies accountable for complaint closure summaries and investigation reports • Track contractual and regulatory deadlines and escalate at-risk cases proactively • Identify and analyze complaint trends across categories such as packaging, cold chain, and dosage • Recommend process changes based on complaint trend findings • Create regular metric reports for senior leadership covering complaint trends, root cause analysis, and action plans • Organize and lead cross-functional meetings with customer experience, pharmacy operations, R&D quality, medical affairs, supplier, and strategic quality teams • Review and concur on third-party complaint investigation findings • Determine complaint investigation outcomes without case-by-case approval from the Director • Use pharmacy expertise to influence workflow changes and product improvements

🎯 Requirements

• Preferably work in the EST time zone • Active Pharmacy Technician or Pharmacist license preferred • Bachelor’s degree in a relevant science, quality, or engineering field preferred; 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 • Knowledge of 21 CFR Parts 210/211, cGMP, and GDP practices • Understanding of USP <795> and <800> standards and non-sterile compounding processes • Strong oral and written communication skills • Experience with complaint or case management platforms such as Zendesk • Ability to manage multiple open investigations simultaneously while maintaining documentation accuracy • Excellent analytical skills to identify trends and root causes across complaint data • Ability to manage multiple tasks and meet deadlines 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 • Pharmacy expertise to influence workflow changes and product improvements related to customer safety and satisfaction

🏖️ Benefits

• Competitive salary • Equity compensation for full-time roles • Unlimited PTO • Company holidays • Quarterly mental health days • Medical, dental, and vision benefits • Parental leave • Employee Stock Purchase Program (ESPP) • 401(k) benefits with employer matching contribution • Offsite team retreats • Talent-first flexible/remote work approach