Associate Director, Audit Strategy and Vendor Quality

Working with Bristol Myers Squibb is an opportunity to engage in challenging and meaningful work that transforms patients’ lives and careers. We value balance, flexibility, and a collaborative culture that empowers teams to innovate.

Working with Bristol Myers Squibb is an opportunity to engage in challenging and meaningful work that transforms patients’ lives and careers. We value balance, flexibility, and a collaborative culture that empowers teams to innovate.

• R&D Quality & Audit Strategy – ope rationalise and execute a risk‑based audit and quality strategy across therapeutic areas, R&D processes, investigator sites, vendors, and digital health, aligning with ICH E6(R3) and regulatory expectations.
• Lead planning, conduct, and reporting of audits and assessments to ensure consistency, quality, and timely delivery in partnership with Clinical Auditing, Development Quality, and business stakeholders.
• Identify, assess, and escalated quality risks, contributing to trend analysis, metrics, and evidence‑based insights.
• Support continuous improvement 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.
• Vendor Quality Oversight, Due Diligence & TPRM – conduct and support vendor due diligence, onboarding assessments, and ongoing quality oversight activities; monitor vendor performance, quality events, and compliance metrics.
• Execute the comprehensive vendor quality oversight framework for CROs and other service providers, implementing Third‑Party Risk Management controls and escalating risks to leadership and governing forums.
• Support development of Clinical Quality Agreements and participate in quality governance for service providers.
• Quality Issues & Investigations – support quality issues, deviations, and investigations, including contributing to root‑cause analysis and remediation planning; escalated critical risks to senior leadership.
• Regulatory, Health Authority & Inspection Readiness – support inspection readiness activities, prepare documentation and quality narratives, and participate in Health Authority inspections.
• Business Partnership, Enablement & M&A – support execution of M&A due diligence activities, evaluate target company GxP readiness, build cross‑functional relationships, and deliver GxP guidance and training.
• Quality Innovation & Organizational Impact – partner with RDQ Digital and cross‑functional teams to execute transformation initiatives that drive automation, data‑driven insights, and efficiency in vendor quality oversight; apply analytics and data science for risk identification and monitoring.

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 environments with strong GCP knowledge.
• Hands‑on experience executing risk‑based audits, vendor oversight, and TPRM activities.
• Experience supporting regulatory inspections and submission readiness.
• Experience managing quality issues, CAPAs, and vendor performance follow‑up.

• Strong working knowledge of ICH/GCP and clinical research processes.
• Applied understanding of quality risk management and trend analysis.
• Clear written and verbal communication skills.
• Strong project management and collaboration skills in a global environment.
• Innovative mindset with interest in improving audit execution, vendor oversight, or quality processes.
• Exposure to data analytics or data science tools supporting quality risk identification and trend analysis.

• Travel up to 20%.
• Hybrid work model is allowed (site‑by‑design).

Princeton – NJ – US: $163,210 – $197,770 (starting range for a full‑time employee).

• Health Coverage – medical, pharmacy, dental, and vision care.
• Well‑being support – BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs.
• Financial protection – 401(k) plan, disability, life insurance, supplemental health insurance, etc.
• Paid Time Off – flexible, unlimited sick time, optional holidays, and a global shutdown.
• Work‑life flexibility – hybrid, remote‑by‑design options and summer hours (eligible employees).

BMS is an equal‑opportunity employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, national origin, disability, or any other protected status.