Senior Manager, Quality Assurance

🕒 Abril 21

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Vera Therapeutics, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

Vera Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico focada no desenvolvimento de tratamentos para doenças renais imunológicas que melhorem a vida dos pacientes. A empresa está avançando com o Atacicept através do desenvolvimento clínico para nefropatia por IgA (IgAN), conduzindo testes de Fase 2b e Fase 3, e perseguindo programas em nefrite lúpica e outras condições imunológicas. Com sede em Brisbane, CA, a Vera enfatiza o desenvolvimento de medicamentos orientado pela ciência, o engajamento com os pacientes e a sustentabilidade.

Descrição

• Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements. • Responsible for implementing strategies and tactics to promote and maintain GxP compliance. • Lead quality aspects of and provide quality support on DP tech transfers. • Liaise with CMO Quality partners to communicate QA policy and procedures. • Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues. • Responsible for material disposition of commercial and clinical DP/ combination products. • Review executed batch records and associated documentation for material disposition. • Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production. • Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc. • Provides assistance during both internal and regulatory agency audits as required • Perform Person-in-Plant duties, as required. • Participate in Material Review Board as required. • Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations. • Act as the Quality representative on assigned product teams to advocate compliance and quality assurance. • Lead for Quality Agreement with external partners. • Support product lifecycle and continued process verification. • Availability for 10-20% travel, both domestically and internationally.

🎯 Requisitos

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred. • Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting. • Minimum 6+ years in a GMP QA role, with a preference for direct experience in biologics sterile DP manufacturing/aseptic processing including vials and prefilled syringes/autoinjectors. • Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators. • Innovative skills with problem solving and peer influence. • In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements. • Experience of working with external partners. • Strong attention to detail is a must. • Excellent interpersonal, written and oral communication skills. • Outstanding organizational skills. • Ability to operate in a fast-paced, multi-disciplinary industrial environment. • Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments. • Familiar with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is a plus.

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Paid time off