Associate Director – Audit Strategy, Vendor Quality

Role Overview

• Support the development and execution of risk-based audit strategies across Therapeutic Areas, R&D processes, and external vendors.
• Operationalize risk-based audit plans, delivering effective audit execution, support quality investigations and CAPA management, as well as proactively identifying and escalating quality risks.
• Lead and support maintaining and applying the vendor quality management framework such as vendor oversight plans, quality agreements, and governance metrics.
• Support inspection readiness and product submission activities through consistent, risk-based quality execution in partnership with RDQ Development Quality and business stakeholders.
• Identify, assess, and escalate quality risks, contributing to trend analysis, metrics, and evidence-based insights.
• Support continuous improvement initiatives by translating audit and inspection findings into actionable corrective and preventive actions, monitoring audit trends and identifying emerging risks.
• Conduct and support vendor due diligence, onboarding assessments, and ongoing quality oversight activities.
• Monitor vendor performance, quality events, and compliance metrics; escalate risks and trends as appropriate.
• Execute on the established comprehensive vendor quality oversight framework for CROs and other service providers.
• Escalate vendor quality risks identified throughout the lifecycle to leadership or in appropriate governing forums in partnership with Development Quality.
• Support the development of Clinical Quality Agreements and participate in the respective quality governance, for service providers.
• Support quality issues, deviations, and investigations, including contributing to root cause analysis and remediation planning, as needed.
• Escalate critical or systemic risks to senior leadership with clear data and recommendations.
• Contribute to trend analysis and risk reporting to support proactive quality management.
• Support inspection readiness activities, including preparation of documentation, metrics, and quality narratives, as needed, in partnership with RDQ Development Quality.
• Participate in Health Authority inspections and contribute to responses and follow-up actions, as needed.
• Provide quality input to product submission activities as required.

Requirements

• 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.

Tech Stack

• Google Cloud Platform

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. 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.