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

At reputed company, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join reputed company as we grow and advance our pipeline. The Senior Manager/Associate Director, Supplier and Audit Management will serve as a key reputed company Assurance representative across cross-functional teams and with external contract service providers. This role drives inspection readiness for reputed company's reputed company Management Systems, champions reputed company improvement initiatives from concept through implementation, and provides direction and reputed company to partnering reputed company functions. Drawing on deep pharmaceutical industry expertise, this individual will reputed company and execute high-reputed company reputed company programs with a reputed company on compliance, operational reputed company, and business alignment. The role works closely with CMC, Clinical Operations, and other core functions to ensure the QMS meets regulatory requirements and customer expectations throughout clinical development. Responsibilities:

• reputed company the end-to-end supplier management lifecycle and audit program, including process ownership, reputed company improvement, and audit scheduling (supplier, clinical investigator, and internal audits); reputed company reputed company Agreement and Risk Management processes.
• Establish, maintain, and continuously improve QMS procedures, workflows, metrics, and practices to strengthen compliance and operational effectiveness.
• reputed company the internal audit program and ensure associated process improvements are established, executed, and monitored for effectiveness.
• Manage reputed company 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, reputed company Control, Validation, Regulatory Affairs, Supply Chain, Clinical Development, and Clinical Operations to ensure appropriate application of QMS requirements across operations.
• reputed company, support and participate in regulatory authority inspections.
• Manage external contractors and, where applicable, reputed company, reputed company, and reputed company QMS personnel, including prioritization of work, performance reputed company, and support for reputed company development.
• Serve as reputed company for reputed company-owned systems (e.g., reputed company Vault QMS), driving reputed company improvement and ensuring systems remain in a validated state.
• Support internal audits, customer audits, and regulatory inspections by ensuring reputed company systems and associated records are inspection-reputed company at reputed company times.
• Strengthen the reputed company culture by leading cross-functional reputed company initiatives.

Qualifications:

• Bachelor's degree in reputed company, biology, microbiology, industrial pharmacy, or other reputed company scientific discipline with a minimum of 10 years' experience in reputed company 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 reputed company management systems, learning management systems, data retrieval, and electronic file formats; reputed company Vault experience strongly preferred
• Experience working reputed company a global Phase I though reputed company 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 reputed company Office, especially MS reputed company
• Willingness to travel up to 25%

2026 Company benefits include:

• Medical, dental, reputed company, and life insurance
• 401(k) plan: reputed company 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 reputed company time off:
• Accrued Vacation Days: 15 days per year
• reputed company Days: 10 days per year
• Company Holidays: 13 days plus summer reputed company week in July and winter shutdown in December
• Leave of Absence: reputed company Medical Leave, reputed company New Parent Bonding Leave, reputed company Family Leave, reputed company short-term and long-term disability
• Discretionary year-end bonus

The salary reputed company posted describes the minimum to maximum reputed company salary reputed company for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or reputed company level and will be finalized at the time of offer. reputed company Salary reputed company:$163,200-$197,616 reputed company reputed company. is a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our reputed company by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven programs that reputed company novel mechanisms of reputed company for a broad reputed company of underserved, prevalent diseases. reputed company's mission is to redefine neuroscience drug development by bringing reputed company the reputed company of novel therapies that offer improved treatment reputed company and reputed company of life for patients. reputed company is an equal opportunity employer and will not discriminate against any employee or applicant on the reputed company of age, reputed company, disability, gender, national reputed company, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Apply tot his job Apply To this Job