Key Responsibilities:

- Help to develop the Quality Narrative at a study and TA level, to document the end-to-end risk-based quality management for critical to quality (CtQ) data, processes and vendors demonstrating effective risk and issue management.

- This will involve collecting all the relevant inputs from the Risk Based Monitoring (RBM) framework Clinical Oversight and Risk Management (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections.

- Work with Drug Development, particularly the CORM function, to embed Quality by Design principles and help identify study specific CtQ data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.

- Provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.

- This will involve partnering with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.

- At the study level, conduct spot checks to ensure risk mitigation strategies are accurately translated into operational plans and verification of action plans are implemented for risk mitigation.

- Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.

- Partner with the study teams to ensure effective management of significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.

- Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.

- Provide R&D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.

- Capture GxP (GCP) Non-compliance events and conduct trend analysis documenting accordingly .

- Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.

- Ensure compliance with ICH (E6, E8, E9) and other relevant regulatory requirements.

- Involved in External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.

Other:

- Champion a culture of quality by delivering forward-looking support across the business ( deviation, CAPA, and process improvement), and consultation through GCP quality and clinical risk management experience .

- Provide analytical support to fellow team members in relation to quality metrics/trending to support critical business programs and assets.

- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.

- Serve as part of strategic team(s) within the group/discipline.

- Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to peers and business partners.

- Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

- Excellent written and verbal English communication skills.

- Analytics and AI tool experience are a plus.

Qualifications & Experience:

- Degree/Certification/Licensure.

- Experience Responsibility and minimum number of years.

- Minimum of 7 years of experience with clinical trials including risk-based monitoring, clinical trial, trial data analysis, identify risk assessment, and reporting.

- At least 5 years of experience in the leading and supporting QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance, audit and inspection.

- Experience with QMS and systems supporting is a plus.

- If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.

- You could be one step away from work that will transform your life and career.

- Uniquely Interesting Work, Life-changing Careers.

- With a single vision as inspiring as Transforming patients' lives through science- , every BMS employee plays an integral role in work that goes far beyond ordinary.