Senior Manager - Quality Risk Analyst

Job Description

Role Overview:Working at Bristol Myers Squibb offers you a chance to be part of a challenging, meaningful, and life-changing work environment. Each day brings uniquely interesting work in every department, from optimizing production lines to groundbreaking advancements in cell therapy. You will have the opportunity to grow and thrive through unique career development opportunities and work alongside high-achieving teams. Bristol Myers Squibb values work-life balance and flexibility, offering competitive benefits and programs to support your personal and professional goals.Key Responsibilities:- Help develop the Quality Narrative at a study and therapeutic area level, documenting end-to-end risk-based quality management for critical to quality (CtQ) data, processes, and vendors with effective risk and issue management.- Collect relevant inputs from the Risk Based Monitoring (RBM) framework Clinical Oversight and Risk Management (CORM) and R&D Quality Clinical Quality Assurance on audits and inspections.- Collaborate with Drug Development, specifically the CORM function, to implement Quality by Design principles, identify study-specific CtQ data, processes, and vendors, and ensure adequate risk mitigation strategies.- Provide feedback on risks related to critical quality factors and adjust mitigation strategies as needed during the trial.- Partner with various teams to gather inputs for Quality by Design, conduct spot checks to ensure accurate translation of risk mitigation strategies into operational plans, and verify implementation of action plans.- Stay informed about current and upcoming regulations, provide regulatory intelligence, and ensure compliance with applicable requirements.- Manage significant quality issues/noncompliance and protocol deviations, monitor CtQ factors throughout the study lifecycle, and adjust Quality plans accordingly.- Share R&D Quality expertise, deliver training, and incorporate best practices and lessons learned into future trials.- Capture GCP Non-compliance events, conduct trend analysis, and ensure rapid communication and escalation of quality issues as needed.- Engage externally with industry associations, regulatory agencies, vendors, and peers as required.Qualifications & Experience:- Minimum of 7 years of experience in clinical trials including risk-based monitoring, trial data analysis, risk assessment, and reporting.- At least 5 years of experience in QA, quality management, biomedical science, clinical development, or regulatory compliance.- Experience with QMS and related systems is a plus.- Strong written and verbal English communication skills.- Experience with analytics and AI tools is advantageous.Note: If you find a role that interests you but doesnt perfectly align with your background, feel free to apply as transformative opportunities may await you at Bristol Myers Squibb. Role Overview:Working at Bristol Myers Squibb offers you a chance to be part of a challenging, meaningful, and life-changing work environment. Each day brings uniquely interesting work in every department, from optimizing production lines to groundbreaking advancements in cell therapy. You will have the opportunity to grow and thrive through unique career development opportunities and work alongside high-achieving teams. Bristol Myers Squibb values work-life balance and flexibility, offering competitive benefits and programs to support your personal and professional goals.Key Responsibilities:- Help develop the Quality Narrative at a study and therapeutic area level, documenting end-to-end risk-based quality management for critical to quality (CtQ) data, processes, and vendors with effective risk and issue management.- Collect relevant inputs from the Risk Based Monitoring (RBM) framework Clinical Oversight and Risk Management (CORM) and R&D Quality Clinical Quality Assurance on audits and inspections.- Collaborate with Drug Development, specifically the CORM function, to implement Quality by Design principles, identify study-specific CtQ data, processes, and vendors, and ensure adequate risk mitigation strategies.- Provide feedback on risks related to critical quality factors and adjust mitigation strategies as needed during the trial.- Partner with various teams to gather inputs for Quality by Design, conduct spot checks to ensure accurate translation of risk mitigation strategies into operational plans, and verify implementation of action plans.- Stay informed about current and upcoming regulations, provide regulatory intelligence, and ensure compliance with applicable requirements.- Manage significant quality issues/noncompliance and protocol deviations, monitor CtQ factors throughout the study lifecycle, and adjust Quality plans accordingly.- Share R&D Quality expertise, deliver training, and incorporate best practices and lessons learned into future trials.- Capture GCP Non-compliance events, conduct trend analysis, and ensure rapid communication a

Keyskills :
Quality ManagementRisk ManagementQuality by DesignRegulatory IntelligenceClinical Risk ManagementProcess ImprovementAnalyticsRisk Based MonitoringClinical OversightGxP GCP ComplianceICH Guidelines