Associate Director, Quality Risk Specialist

Role Summary

Associate Director, Quality Risk Specialist responsible for developing the Quality Narrative for end-to-end RBQM for CtQ data, processes, and vendors, and providing quality and compliance consultation throughout the study lifecycle. Establishes feedback loops to adjust mitigation strategies as issues arise and ensures regulatory alignment.

Responsibilities

• Develop the Quality Narrative at the study/ASSET/TA level to document end-to-end risk-based quality management for CtQ data, processes and vendors.
• Embed Quality by Design principles during upstream protocol authoring and identify CtQ data, processes and vendors with adequate risk mitigation strategies.
• Provide feedback on risks during trial conduct and adjust mitigation strategies as new issues arise; collaborate with CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance to inform QbD.
• Conduct quality assurance spot checks at the study level to ensure mitigation strategies are translated into operational plans.
• Assist in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
• Support for cause, critical and/or complex quality issues and serious breaches for the TA as needed.
• Provide regulatory intelligence to ensure compliance with applicable requirements; establish strong partnerships with stakeholders.
• Manage CtQ factors across the study lifecycle and adapt Quality plans accordingly.
• Provide R&D Quality expertise, training, and share best practices for future trials.
• Ensure rapid communication and escalation of quality issues to the business and Health Authorities as needed.
• Ensure compliance with ICH (E8, E6, E9) and other regulatory requirements; engage externally with industry/QA associations, regulatory agencies, vendors, and peers.

Qualifications

• B.S. and/or M.S. in Chemistry, Biology, Health or Quality-related field or equivalent experience.
• Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.

Required Competencies

• Applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and Quality Assurance principles.
• Experience with Risk Based Quality Management principles and applied risk-management (risk assessment, analysis, evaluation, reporting, communication, treatment, and continuous risk management).
• Understanding of BMS therapeutic areas (HOCT and ICN).
• Regulatory inspection preparation, management, and follow-up experience.
• Analytical and conceptual capability with data-driven decision making; strong problem-solving skills for clinical program implementation.
• Effective written and verbal communication and presentation skills; professional interaction with internal and external stakeholders.
• Project management skills to manage complex assignments and deliver deliverables on time; ability to adapt to global/regional differences.
• Global thinking and adaptability; fosters continuous service and process improvement.

Skills

• Quality Risk Management
• Regulatory Compliance
• Quality Assurance Audits and CAPA
• Quality by Design (QbD)
• CtQ Data and KPIs
• Cross-functional Leadership

Education

• As listed in Qualifications

Additional Requirements

• Hybrid work model eligibility and site-based requirements as applicable.