The Director, GCP Audit Strategy and Vendor Quality is accountable for designing and executing a global, risk-based audit strategy to ensure compliance with Good Clinical Practice (GCP) requirements.
Lead strategic planning for audits, managing vendor-related quality investigations, CAPA development, and ensuring timely resolution of quality issues.
Establish and maintain a comprehensive vendor quality management framework for CROs and other external partners.
Oversee vendor quality programs and collaboration with cross-functional teams within RDQ, Outsourcing Management, and Procurement.
Monitor audit, inspection trends/metrics and identify process, program, and vendor risks.
Provide strategic leadership for vendor quality oversight, ensuring independence, objectivity, and alignment with regulatory expectations.
Define expectations and governance for Third-Party Risk Management (TPRM).
Lead Quality due diligence and integration for M&A transactions related to R&D activities.
Champion and embed Quality by Design principles across Clinical third-party engagements.

Requirements

B.S. or M.S. in a scientific, health, IT, or quality-related discipline (or equivalent experience)
12+ years in Quality Assurance or regulated clinical development environments with strong GCP knowledge
Proven leadership of global audit strategy, vendor quality, and TPRM programs
Demonstrated experience with Health Authority inspections, senior regulatory engagement, and inspection readiness
Experience leading complex investigations, serious breaches, and high-risk vendor issues
Direct involvement in M&A, in-licensing, and due diligence from a quality perspective
Expert knowledge of ICH/GCP and global regulatory requirements
Strong applied risk management and data-driven decision-making capability
Executive-level communication and influencing skills
Ability to lead strategy, drive change, and operate effectively in a global matrix
Innovative and transformative mindset, with experience automating audit risk assessment models, vendor oversight, or quality systems and processes
Data science or advanced analytics experience (e.g., risk-based analytics, dashboards, AI-enabled quality insights).

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Good Clinical Practice (GCP)Quality AssuranceThird-Party Risk Management (TPRM)Health Authority inspectionsM&A due diligenceICH/GCPrisk managementdata-driven decision-makingaudit strategyquality systems

Soft Skills

leadershipexecutive-level communicationinfluencing skillsstrategic planningchange managementinnovative mindsettransformative mindsetcollaborationproblem-solvingcross-functional teamwork