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

📋 Description

• Manage the complete supplier management lifecycle and audit program, which includes process ownership, ongoing enhancement, and scheduling of audits (supplier, clinical investigator, and internal audits); oversee the Quality Agreement and Risk Management processes.

• Develop, sustain, and enhance QMS procedures, workflows, metrics, and practices to bolster compliance and operational efficiency.

• Supervise the internal audit program, ensuring that process improvements are implemented, executed, and assessed for effectiveness.

• Oversee all documentation and records retention related to supplier and audit management, encompassing document routing, approval, archival, and periodic review.

• Collaborate with Manufacturing, Quality Control, Validation, Regulatory Affairs, Supply Chain, Clinical Development, and Clinical Operations to guarantee the proper implementation of QMS requirements across all operations.

• Lead, support, and engage in inspections by regulatory authorities.

• Manage external contractors and, when applicable, guide, mentor, and develop QMS personnel, including task prioritization, performance oversight, and support for professional growth.

• Act as the business owner for Quality-owned systems (e.g., Veeva Vault QMS), promoting continuous improvement and ensuring systems remain validated.

• Assist with internal audits, customer audits, and regulatory inspections by ensuring that quality systems and related records are always inspection-ready.

• Enhance the Quality culture by spearheading cross-functional Quality initiatives.

⛳️ Requirements

• Bachelor’s degree in chemistry, biology, microbiology, industrial pharmacy, or another relevant scientific field, with at least 10 years of experience in Quality preferred.

• Experience in auditing suppliers, CRPs, CMOs, CTLs, and clinical sites.

• Practical understanding of supplier and audit management within US, EU, and ROW regulated environments.

• Familiarity with electronic quality management systems, learning management systems, data retrieval, and electronic file formats; experience with Veeva Vault is highly preferred.

• Experience in a global Phase I through commercial QMS organization.

• Detail-oriented with excellent communication, organizational, and time management skills is essential.

• Ability to multitask, work under pressure, solve problems, and prioritize effectively.

• Highly skilled in Microsoft Office, particularly 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 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.