Senior Manager, Quality Chemistry Manufacturing and Controls – Drug Product

🕒 Julho 31

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $135.000 - $165.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

👻 Score fantasma 7%

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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Sabin Vaccine Institute

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1993

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

💰 $35.000.000 Grant em 2023-01

Healthcare • Consulting • Food & Beverage

O Instituto de Vacinas Sabin se dedica a melhorar a saúde global, garantindo o acesso a vacinas que salvam vidas. O instituto foca em pesquisa e desenvolvimento de novas vacinas para algumas das doenças mais urgentes do mundo, incluindo cólera, HPV, malária, Marburg e Ebola. Através de programas e parcerias inovadoras, a Sabin busca melhorar as capacidades de imunização e a aceitação de vacinas dentro das comunidades, esforçando-se para tornar a vacinação acessível a todos, especialmente às populações vulneráveis.

Descrição

• Serve as primary Quality representative, providing cGMP oversight and risk-based quality decision-making across clinical and late-stage DP activities • Provide Quality oversight for clinical manufacturing, engineering runs, technology transfer, scale-up activities, process validation, and PPQ readiness • Participate in manufacturing readiness reviews and provide Quality approval for validation, media fills, PPQ execution, and commercial readiness activities • Review batch records, deviations, investigations, analytical and stability data, environmental monitoring results, and change controls to support product disposition decisions • Approve deviations, Corrective and Preventative Actions (CAPAs), change controls, risk assessments, and quality records supporting compliant operations • Provide Quality oversight of Contract Development Manufacturing Organizations (CDMOs) and contract laboratories, including supplier qualification, audits, inspection support, and CAPA implementation • Support preparation of quality documentation and responses associated with Biological License Application (BLA), Marketing Authorization Application (MAA), and other regulatory submissions • Support regulatory inspections, including the Food and Drug Administration (FDA) inspections, Bioresearch Monitoring (BIMO) inspections, and Pre-Approval Inspections (PAIs) • Lead the development, implementation, and continuous improvement of Sabin's Quality Management System, quality governance, and sponsor oversight processes to support the organization's transition to a fully compliant global Marketing Authorization Holder (MAH)

🎯 Requisitos

• Bachelor’s or advanced degree in scientific discipline • 9+ years of Quality experience supporting biologics, vaccines, or pharmaceutical DP manufacturing • Proven experience supporting technology transfer, process validation, PPQ execution, manufacturing readiness, and commercial launch preparation • Demonstrated experience providing Quality oversight of aseptic manufacturing and fill-finish CDMOs • Experience supporting FDA inspections, BIMO inspections, and/or PAIs • Strong knowledge of 21 CFR Parts 210 and 211, Annex 1, ICH Q10, and global cGMP requirements applicable to sterile drug product manufacturing • Experience supporting BLA, MAA, or equivalent regulatory submissions preferred • Occasional travel required to support organizational alignment and business needs

🏖️ Benefícios

• medical, dental, and vision coverage • flexible spending accounts • flexible vacation and sick leave • employer-paid life and disability insurance • 11 federal holidays • end-of-year winter break • employer-matching 401(k) plan