Associate Director, Audit Strategy and Vendor Quality

Overview

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. Bristol Myers Squibb offers work that transforms patients’ lives and provides opportunities to grow with high-achieving teams. Balance and flexibility are part of our environment, with a variety of benefits and programs to support employees’ goals at work and in their personal lives.

The Associate Director, Audit Strategy and Vendor Quality supports the development and execution of risk-based audit strategies across Therapeutic Areas, R&D processes, and external vendors. This role focuses on operationalizing risk-based audit plans, delivering effective audit execution, supporting quality investigations and CAPA management, and proactively identifying and escalating quality risks. The role leads and supports vendor quality management, including vendor oversight plans, quality agreements, and governance metrics, and supports inspection readiness and product submission activities through consistent, risk-based quality execution in partnership with RDQ Development Quality and business stakeholders.

• Operationalize and execute 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 planning, conduct, and reporting of audits and assessments with appropriate partnerships
• Identify, assess, and escalate quality risks; contribute to trend analysis, metrics, and evidence-based insights
• Support continuous improvement by translating findings into corrective and preventive actions and monitoring trends
• Support Quality by Design principles within assigned programs and processes

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

• Support quality issues, deviations, and investigations; contribute to root cause analysis and remediation planning
• Escalate critical or systemic risks to senior leadership with data and recommendations
• Contribute to trend analysis and risk reporting for proactive quality management

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

• Support M&A due diligence for evaluating target company GxP readiness and risks from a quality perspective
• Build strong cross-functional relationships and provide independent quality guidance for decision-making
• Deliver GxP guidance and training to strengthen quality awareness and execution

• Collaborate with RDQ Digital and cross-functional teams to drive automation and data-driven insights in vendor quality oversight
• Apply analytics to enhance risk identification and decision-making
• Monitor external trends and regulations; translate insights into practical process improvements

• B.S. or M.S. in a scientific, health, or quality-related discipline (or equivalent experience)

• 8+ years in Quality Assurance or regulated clinical development with strong GCP knowledge
• Hands-on experience with risk-based audits, vendor oversight, and TPRM
• Experience supporting regulatory inspections and submission readiness
• Experience managing quality issues, CAPAs, and vendor performance…