Quality Compliance Specialist, Post Market Surveillance

🕒 Setembro 11

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $90.000 - $115.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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hims & hers

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2017

🏥 Saúde

💼 Consultoria

📣 Marketing

Healthcare • Consulting • Marketing

A Hims & Hers é uma plataforma de saúde 100% online que fornece atendimento personalizado e consultas para saúde sexual, crescimento capilar, perda de peso, cuidados com a pele e saúde mental. Com mais de 2 milhões de assinantes, a Hims & Hers conecta pacientes a profissionais de saúde licenciados, oferecendo medicamentos prescritos e suporte contínuo entregues diretamente em suas casas. A plataforma tem como objetivo tornar o atendimento médico acessível, econômico e discreto, garantindo que os usuários possam gerenciar seu tratamento convenientemente através de um aplicativo.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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