Director, Audit Strategy and Vendor Quality

Bristol Myers Squibb • Princeton, NJ

14d • Hybrid

About The Position

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. This role will drive robust vendor quality oversight across all clinical trial service providers in close partnership with Development Quality. Key responsibilities include leading strategic planning for audits, managing vendor-related quality investigations, CAPA development, and ensuring timely resolution of quality issues. The Director will establish and maintain a comprehensive vendor quality management framework for CROs and other external partners. This includes oversight of vendor quality programs and collaboration with cross-functional teams within RDQ, Outsourcing Management, and Procurement to embed proactive and predictive quality principles into vendor oversight. Core elements of this framework may encompass quality agreements, vendor quality oversight plans, governance structures, and continuous improvement initiatives to strengthen compliance and quality culture across the vendor network. R&D Quality, Audit Strategy Design and implement a global, risk-based GCP audit strategy (programs, process, investigator sites, Service Providers aligned with ICH E6(R3), regulatory expectations, and company objectives. Lead and engage with business stakeholders to develop an integrated Global Audit Plan. Establish and evolve the Vendor Quality and TPRM strategy, ensuring consistent risk classification, due diligence, onboarding, oversight, and exit across the third-party lifecycle Monitor audit, inspection trends/metrics and identify process, program, and vendor risks, and develop predictive analytics to proactively identify emerging risks and drive continuous improvement leveraging external intelligence Champion and embed Quality by Design principles across Clinical third-party engagements Vendor Quality Oversight, Due Diligence & TPRM Provide strategic leadership for vendor quality oversight, ensuring independence, objectivity, and alignment with regulatory expectations Establish and maintain a comprehensive vendor quality oversight framework for GCP service providers Partner with Procurement, Outsourcing Management, Clinical Operations and Development Quality to ensure vendor qualification, performance monitoring, and issue resolution. Support and drive governance forums (where applicable) with key vendors to ensure compliance and quality culture and regulatory expectation Lead and oversee vendor due diligence activities, including risk assessments, audits, and quality evaluations for M&A, in-licensing, outsourcing, and strategic partnerships Define expectations and governance for Third-Party Risk Management (TPRM), including risk stratification, audit frequency, issue escalation, and performance monitoring Partner with Development Quality and applicable business functions to assure vendor quality risks are proactively identified, trended, and addressed throughout the vendor lifecycle Leads the development of Clinical Quality Agreements and the set-up of the respective quality governance, for preferred/critical service providers where applicable Define and drive KRIs/KQIs with key vendors and establish clear accountability, cadence, and measurable outcomes. R&D Quality, Audit Strategy Design and implement a global, risk-based GCP audit strategy (programs, process, investigator sites, Service Providers aligned with ICH E6(R3), regulatory expectations, and company objectives. Lead and engage with business stakeholders to develop an integrated Global Audit Plan. Establish and evolve the Vendor Quality and TPRM strategy, ensuring consistent risk classification, due diligence, onboarding, oversight, and exit across the third-party lifecycle Monitor audit, inspection trends/metrics and identify process, program, and vendor risks, and develop predictive analytics to proactively identify emerging risks and drive continuous improvement leveraging external intelligence Champion and embed Quality by Design principles across Clinical third-party engagements Vendor Quality Oversight, Due Diligence & TPRM Provide strategic leadership for vendor quality oversight, ensuring independence, objectivity, and alignment with regulatory expectations Establish and maintain a comprehensive vendor quality oversight framework for GCP service providers Partner with Procurement, Outsourcing Management, Clinical Operations and Development Quality to ensure vendor qualification, performance monitoring, and issue resolution. Support and drive governance forums (where applicable) with key vendors to ensure compliance and quality culture and regulatory expectation Lead and oversee vendor due diligence activities, including risk assessments, audits, and quality evaluations for M&A, in-licensing, outsourcing, and strategic partnerships Define expectations and governance for Third-Party Risk Management (TPRM), including risk stratification, audit frequency, issue escalation, and performance monitoring Partner with Development Quality and applicable business functions to assure vendor quality risks are proactively identified, trended, and addressed throughout the vendor lifecycle Leads the development of Clinical Quality Agreements and the set-up of the respective quality governance, for preferred/critical service providers where applicable Define and drive KRIs/KQIs with key vendors and establish clear accountability, cadence, and measurable outcomes. Investigations, Escalations & Critical Issues Lead and/or support for-cause, critical, and complex investigations, involving internal processes and/or vendors, ensuring robust root cause analysis and sustainable remediation, as needed Regulatory, Health Authority Inspection Readiness Ensure inspection readiness in partnership with Development Quality, and Outsourcing Management , clearly demonstrating effective vendor oversight and TPRM controls Partner with Development Quality Asset Leads to ensure vendor inspection readiness across programs Provide strategic guidance during regulatory inspections and lead remediation planning for audit findings Business Partnership, M&A & Leadership Lead Quality due diligence and integration for M&A transactions related to R&D activities. Establish proactive and predictive quality practices for M&A activities to protect patient safety, data reliability, and regulatory compliance through acquisition, carve-outs, asset integrations, and alliances/partnerships. Lead Quality input for M&A, in-licensing, and alliance governance, including due diligence, integration planning, and post-deal oversight Partner with teams across RDQ and GQ to support clear quality narrative, integrating audit outcomes, vendor performance, metrics, and risk insights to drive M&A related executive decision-making Partner in building training content for consistent understanding of vendor quality and regulatory requirements Innovation & External Engagement Partner with RDQ digital leads to support automation and build efficiencies in existing processes Promote a culture of innovation, quality, risk management, and continuous improvement Consistently assess the external landscape and stays informed about industry practices and new developments in vendor quality oversight Serve as a Quality Relationship Manager for key service providers relevant for vendor quality initiatives within and across the organization.

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

Nice To Haves

• Data science or advanced analytics experience (e.g., risk-based analytics, dashboards, AI-enabled quality insights).

Responsibilities

• Designing and executing a global, risk-based audit strategy to ensure compliance with Good Clinical Practice (GCP) requirements
• Driving robust vendor quality oversight across all clinical trial service providers in close partnership with Development Quality
• Leading strategic planning for audits
• Managing vendor-related quality investigations
• CAPA development
• Ensuring timely resolution of quality issues
• Establishing and maintaining a comprehensive vendor quality management framework for CROs and other external partners
• Overseeing vendor quality programs
• Collaborating with cross-functional teams within RDQ, Outsourcing Management, and Procurement to embed proactive and predictive quality principles into vendor oversight
• Leading and engaging with business stakeholders to develop an integrated Global Audit Plan
• Establishing and evolving the Vendor Quality and TPRM strategy, ensuring consistent risk classification, due diligence, onboarding, oversight, and exit across the third-party lifecycle
• Monitoring audit, inspection trends/metrics and identify process, program, and vendor risks, and develop predictive analytics to proactively identify emerging risks and drive continuous improvement leveraging external intelligence
• Championing and embedding Quality by Design principles across Clinical third-party engagements
• Providing strategic leadership for vendor quality oversight, ensuring independence, objectivity, and alignment with regulatory expectations
• Partnering with Procurement, Outsourcing Management, Clinical Operations and Development Quality to ensure vendor qualification, performance monitoring, and issue resolution
• Supporting and driving governance forums (where applicable) with key vendors to ensure compliance and quality culture and regulatory expectation
• Leading and overseeing vendor due diligence activities, including risk assessments, audits, and quality evaluations for M&A, in-licensing, outsourcing, and strategic partnerships
• Defining expectations and governance for Third-Party Risk Management (TPRM), including risk stratification, audit frequency, issue escalation, and performance monitoring
• Partnering with Development Quality and applicable business functions to assure vendor quality risks are proactively identified, trended, and addressed throughout the vendor lifecycle
• Leading the development of Clinical Quality Agreements and the set-up of the respective quality governance, for preferred/critical service providers where applicable
• Defining and driving KRIs/KQIs with key vendors and establish clear accountability, cadence, and measurable outcomes
• Leading and/or support for-cause, critical, and complex investigations, involving internal processes and/or vendors, ensuring robust root cause analysis and sustainable remediation, as needed
• Ensuring inspection readiness in partnership with Development Quality, and Outsourcing Management , clearly demonstrating effective vendor oversight and TPRM controls
• Partnering with Development Quality Asset Leads to ensure vendor inspection readiness across programs
• Providing strategic guidance during regulatory inspections and lead remediation planning for audit findings
• Leading Quality due diligence and integration for M&A transactions related to R&D activities
• Establishing proactive and predictive quality practices for M&A activities to protect patient safety, data reliability, and regulatory compliance through acquisition, carve-outs, asset integrations, and alliances/partnerships
• Leading Quality input for M&A, in-licensing, and alliance governance, including due diligence, integration planning, and post-deal oversight
• Partnering with teams across RDQ and GQ to support clear quality narrative, integrating audit outcomes, vendor performance, metrics, and risk insights to drive M&A related executive decision-making
• Partnering in building training content for consistent understanding of vendor quality and regulatory requirements
• Partnering with RDQ digital leads to support automation and build efficiencies in existing processes
• Promoting a culture of innovation, quality, risk management, and continuous improvement
• Consistently assessing the external landscape and stays informed about industry practices and new developments in vendor quality oversight
• Serving as a Quality Relationship Manager for key service providers relevant for vendor quality initiatives within and across the organization

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director