Support the development and execution of risk-based audit strategies across Therapeutic Areas, R&D processes, and external vendors.
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.
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.
Support quality issues, deviations, and investigations, including contributing to root cause analysis and remediation planning, as needed.
Support inspection readiness activities, including preparation of documentation, metrics, and quality narratives, as needed, in partnership with RDQ Development Quality.
Build strong working relationships with cross-functional stakeholders, understanding priorities and providing independent quality guidance.

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.

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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

risk-based auditsvendor oversightquality assuranceGCP knowledgeCAPAsquality risk managementtrend analysisregulatory inspectionsclinical research processesdata analytics

Soft Skills

clear communicationproject managementcollaborationinnovative mindsetrelationship buildingquality guidanceproblem-solvinganalytical thinkingattention to detailadaptability