Associate Director, Audit Strategy and Vendor Quality

Working with UsChallenging. Meaningful. Life-changing. Those aren't 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. You'll 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 careers.bms.com/working-with-us .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, as well as proactively identifying and escalating quality risks. The Associate Director will lead and support maintaining and applying the vendor quality management framework such as 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.R&D Quality, Audit StrategyOperationalize and execute the 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 objectivesLead the planning, conduct, and reporting of audits and assessments, ensuring consistency, quality, and timely delivery, in partnership with Clinical Auditing team, Development Quality and business stakeholdersIdentify, assess, and escalate quality risks, contributing to trend analysis, metrics, and evidence-based insightsSupport continuous improvement initiatives by translating audit and inspection findings into actionable corrective and preventive actions, monitoring audit trends and identifying emerging risksSupport implementation of Quality by Design principles within assigned programs and processesVendor Quality Oversight, Due Diligence & TPRMConduct and support vendor due diligence, onboarding assessments, and ongoing quality oversight activitiesMonitor vendor performance, quality events, and compliance metrics; escalate risks and trends as appropriateExecute on the established comprehensive vendor quality oversight framework for CROs and other service providersImplement Third-Party Risk Management (TPRM) controls in alignment with established governance, including vendor risk classification, oversight planning, and documentationEscalate vendor quality risks identified throughout the lifecycle to leadership or in appropriate governing forums in partnership with Development QualitySupport the development of Clinical Quality Agreements and participate in the respective quality governance, for service providersQuality Issues & InvestigationsSupport quality issues, deviations, and investigations, including contributing to root cause analysis and remediation planning, as neededEscalate critical or systemic risks to senior leadership with clear data and recommendationsContribute to trend analysis and risk reporting to support proactive quality managementRegulatory, Health Authority & Inspection ReadinessSupport inspection readiness activities, including preparation of documentation, metrics, and quality narratives, as needed, in partnership with RDQ Development QualityParticipate in Health Authority inspections and contribute to responses and follow-up actions, as neededProvide quality input to product submission activities as requiredBusiness Partnership, Enablement and M&ASupport execution of M&A due diligence activities based on the established M&A framework for evaluating target company GxP readiness and risks from a quality perspectiveBuild strong working relationships with cross-functional stakeholders, understanding priorities and providing independent quality guidanceProvide independent quality guidance and present compliance, conformance, issues, and risks to support informed decision-makingDeliver GxP guidance and training to business partners to strengthen quality awareness and execution, as neededQuality Innovation & Organizational Impact Partner with RDQ Digital and cross-functional teams to execute and implement transformation initiatives that drive automation, data-driven insights, and efficiency in vendor quality oversight processesApply analytics and data science approaches to enhance risk identification, monitoring, and decision-making within vendor oversightMonitor external trends, evolving regulations, and industry best practices in vendor quality and oversight, and translate relevant insights into practical improvements to existing processesEducationB.S. or M.S. in a scientific, health, or quality-related discipline (or equivalent experience)Experience8+ years in Quality Assurance or regulated clinical development environments with strong GCP knowledgeHands-on experience executing risk-based audits, vendor oversight, and TPRM activitiesExperience supporting regulatory inspections and submission readinessExperience managing quality issues, CAPAs, and vendor performance follow-upExpertise & SkillsStrong working knowledge of ICH/GCP and clinical research processesApplied understanding of quality risk management and trend analysisClear written and verbal communication skillsStrong project management and collaboration skills in a global environmentInnovative 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.TravelUp to 20%If you come across a role that intrigues you but doesn't 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.Compensation OverviewPrinceton - NJ - US $163,210 - $197,770The 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 employee's 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 https //careers.bms.com/life-at-bms/.Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits includeHealth 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. 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 CareersWith 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 ProtocolBMS 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 roleSite-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 DisabilitiesBMS 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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.Candidate RightsBMS 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 https //careers.bms.com/california-residents/Data ProtectionWe will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection .Any 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 TAEnablement@bms.com . 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.R1600062 Associate Director, Audit Strategy and Vendor Quality