Caregiver Jobs

About The Position

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.

Responsibilities

• 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

Benefits

• Medical, pharmacy, dental, and vision care
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• 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
• survivor support
• flexible time off (unlimited, with manager approval)
• 11 paid national holidays
• 160 hours annual paid vacation for new hires with manager approval
• 3 optional holidays
• 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
• annual Global Shutdown between Christmas and New Years Day