Director, Audit Strategy and Vendor Quality

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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.

Education

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

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

Expertise & Skills

• 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).

Travel

• Up to 30%
• #LI-HYBRID

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.