Associate Director – Audit Strategy, Vendor Quality

Role Overview

• Operationalize 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 objectives.
• Lead 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 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.
• Support implementation of Quality by Design principles within assigned programs and processes.
• 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.
• Implement Third-Party Risk Management (TPRM) controls in alignment with established governance, including vendor risk classification, oversight planning, and documentation.
• 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.
• Support 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 perspective.
• Build strong working relationships with cross-functional stakeholders, understanding priorities and providing independent quality guidance.
• Provide independent quality guidance and present compliance, conformance, issues, and risks to support informed decision-making.
• Deliver GxP guidance and training to business partners to strengthen quality awareness and execution, as needed.
• 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 processes.
• Apply analytics and data science approaches to enhance risk identification, monitoring, and decision-making within vendor oversight.
• Monitor external trends, evolving regulations, and industry best practices in vendor quality and oversight, and translate relevant insights into practical improvements to existing processes.

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: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.