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

Responsibilities

• 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.

Qualifications

• 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, CROs, 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%

Benefits

• Medical, dental, vision, and life insurance
• 401(k) plan: Neumora matches 50% of an employee's eligible contribution, up to the first