Associate Director, Audit Strategy and Vendor Quality

Working with Us

Challenging. Meaningful. Life‑changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:

• Operationalize and execute the risk‑based audit and quality strategy across Therapeutic Areas, R&D processes, investigator sites, vendors, and digital health aligned with ICH E6(R3), regulatory expectations, and company objectives.
• Lead the planning, conduct, and reporting of audits and assessments, ensuring consistency, quality, and timely delivery, in partnership with Clinical Auditing team, Development Quality and business stakeholders.
• Identify, assess, and elevate quality risks, contributing to trend analysis, metrics, and evidence‑based insights.
• Support continuous improvement initiatives by translating audit and inspection findings into actionable corrective and preventive actions, monitoring audit trends and identifying emerging risks.
• Support implementation of Quality by Design principles within assigned programs and processes.

• Conduct and support vendor due diligence, onboarding assessments, and ongoing quality oversight activities.
• Monitor vendor performance, quality events, and compliance metrics; escalate risks and trends as appropriate.
• Execute on the established comprehensive vendor quality oversight framework for CROs and other service providers.
• Implement Third‑Party Risk Management (TPRM) controls in alignment with established governance, including vendor risk classification, oversight planning, and documentation.
• Escalate vendor quality risks identified throughout the lifecycle to leadership or in appropriate governing forums in partnership with Development Quality.
• Support the development of Clinical Quality Agreements and participate in the respective quality governance for service providers.

• Support quality issues, deviations, and investigations, including contributing to root cause analysis and remediation planning, as needed.
• Escalate critical or systemic risks to senior leadership with clear data and recommendations.
• Contribute to trend analysis and risk reporting to support proactive quality management.

• Support inspection readiness activities, including preparation of documentation, metrics, and quality narratives, as needed, in partnership with RDQ Development Quality.
• Participate in Health Authority inspections and contribute to responses and follow‑up actions, as needed.
• Provide quality input to product submission activities as required.

• Support execution of M&A due diligence activities based on the established M&A framework for evaluating target company GxP readiness and risks from a quality perspective.
• Build strong working relationships with cross‑functional stakeholders, understanding priorities and providing independent quality guidance.
• Provide independent quality guidance and present compliance, conformance, issues, and risks to support informed decision‑making.
• Deliver GxP guidance and training to business partners to strengthen quality awareness and execution, as needed.

• Partner with RDQ Digital and cross‑functional teams to execute and implement transformation initiatives that drive automation, data‑driven insights, and efficiency in vendor quality oversight processes.
• Apply…