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

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Neumora

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51 - 200 Mitarbeiter

Gegründet 2021

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

Biotechnology • Pharmaceuticals • Science

Neumora definiert die Entwicklung von Arzneimitteln in der Neurowissenschaft neu, indem es eine neue Ära der Präzisionsmedizin für Gehirnerkrankungen einleitet. Mit dem Fokus auf der Entwicklung gezielter und effektiver Therapien strebt Neumora an, die globale Gehirnerkrankungskrise anzugehen, die über 1,5 Milliarden Menschen betrifft. Ihr innovativer Ansatz konzentriert sich auf die Entwicklung therapeutisch relevanter Ziele bei Erkrankungen des Zentralnervensystems (ZNS), mit Betonung auf neuartige Wirkmechanismen und erstklassige Pharmakologie. Die Bemühungen des Unternehmens werden durch ihr Precision Toolbox unterstützt, das transnationale, klinische und computergestützte Werkzeuge integriert, um Ansätze der Präzisionsmedizin voranzutreiben. Neumora hat sich verpflichtet, die zukünftige Behandlung von Gehirnerkrankungen zu transformieren, indem ein Team engagierter Arzneimittelentwickler und Datenwissenschaftler im Bereich der Neurowissenschaft aufgebaut wird.

Beschreibung

• 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.

🎯 Anforderungen

• 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%

🏖️ Vorteile

• 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