Senior Manager/Associate Director, Supplier and Audit Management – Biotech/Pharma Experience Required

🕒 Maio 7

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Neumora

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2021

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

Biotechnology • Pharmaceuticals • Science

A Neumora está redefinindo o campo do desenvolvimento de medicamentos para neurociência ao inaugurar uma nova era de medicamentos de precisão para doenças cerebrais. Com foco no desenvolvimento de terapias direcionadas e eficazes, a Neumora visa enfrentar a crise global de doenças cerebrais que afeta mais de 1,5 bilhão de pessoas. Sua abordagem inovadora gira em torno do desenvolvimento de alvos terapeuticamente relevantes em doenças do Sistema Nervoso Central (SNC), enfatizando novos mecanismos de ação e farmacologia de classe mundial. Os esforços da empresa são apoiados por sua Caixa de Ferramentas de Precisão, que integra ferramentas translacionais, clínicas e computacionais para avançar nas abordagens de medicina de precisão. A Neumora está comprometida em transformar o futuro do tratamento de doenças cerebrais ao reunir uma equipe de desenvolvedores dedicados de medicamentos para neurociência e cientistas de dados.

Descrição

• Lead the end-to-end supplier management lifecycle and audit program, including process ownership, continuous improvement, and audit scheduling (supplier, clinical investigator, and internal audits); oversee Quality Agreement and Risk Management processes. • Establish, maintain, and continuously improve QMS procedures, workflows, metrics, and practices to strengthen compliance and operational effectiveness. • Oversee the internal audit program and ensure associated process improvements are established, executed, and monitored for effectiveness. • Manage all aspects of documentation and records retention for supplier and audit management, including the routing and approval of documents, archival, and period review. • Partner with Manufacturing, Quality Control, Validation, Regulatory Affairs, Supply Chain, Clinical Development, and Clinical Operations to ensure appropriate application of QMS requirements across operations. • Lead, support and participate in regulatory authority inspections. • Manage external contractors and, where applicable, lead, coach, and develop QMS personnel, including prioritization of work, performance oversight, and support for professional development. • Serve as business owner for Quality-owned systems (e.g., Veeva Vault QMS), driving continuous improvement and ensuring systems remain in a validated state. • Support internal audits, customer audits, and regulatory inspections by ensuring quality systems and associated records are inspection-ready at all times. • Strengthen the Quality culture by leading cross-functional Quality initiatives.

🎯 Requisitos

• Bachelor’s degree in chemistry, biology, microbiology, industrial pharmacy, or other related scientific discipline with a minimum of 10 years’ experience in Quality preferred • Experience auditing suppliers, CRPs, CMOs, CTLs and clinical sites • Practical knowledge of supplier and audit management across US, EU and ROW regulated environments • Working knowledge of electronic quality management systems, learning management systems, data retrieval, and electronic file formats; Veeva Vault experience strongly preferred • Experience working within a global Phase I though commercial QMS company • Detail-oriented with strong communication, organizational, and time management skills a must • Ability to multitask, work under time constraints, problem-solve, and prioritize • Highly proficient in Microsoft Office, especially MS Excel • Willingness to travel up to 25%

🏖️ Benefícios

• Medical, dental, vision, and life insurance • 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution) • Company Equity (New Hire Awards, Annual Awards, ESPP) • Annual paid time off: • Accrued Vacation Days: 15 days per year • Sick Days: 10 days per year • Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December • Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability • Discretionary year-end bonus