Associate Director, R&D Quality Governance

Role Summary

The Associate Director will be responsible for implementation of an effective R&D Quality & Risk Governance framework across nonclinical, clinical and pharmacovigilance functions that empowers decision-making through data-driven insights, cross-functional collaboration and continuous innovation. Ensuring that key highlights, areas of excellence, and risks are escalated to relevant governance bodies in a proportionate manner, with a focus on significant matters that impact the business.

Responsibilities

• Support the implementation of an effective R&D Quality Risk Governance framework in alignment with Enterprise Risk Management principles.
• Facilitate the roll-up of relevant R&D risks and insights for reporting to Global Quality Councils, Enterprise Risk Committees, and relevant Drug Development Governance forums and assure alignment with regulatory requirements, industry standards, and best practices.
• Partner with Quality Council Co-Chairs, to support continuous assessment, evaluation, and communication of strategic / quality / operational risks within R&D.
• Support the GCP serious non-compliance management process, including management of Serious Breaches.
• Conduct comprehensive data analysis and interrogation of data to derive meaningful, actionable insights that support data-driven decision-making at Global GxP Quality Councils.
• Support CAPA management by facilitating root cause investigations, review and approval of CAPA plans.
• Partner with Global Quality to ensure quality metrics are aligned with organizational goals, regulatory requirements, and support development of tools and reports to drive inspection readiness.
• Partner with Global Quality to provide insights on quality, compliance and operational risks to products in clinical trials and post marketing.
• 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.
• Champion a Quality Mindset and ensure compliance with key ICH guidelines (E8, E6, E9, Q9) and other relevant regulatory requirements.

Qualifications

• Minimum 10+ years QA experience or relevant experience in quality management, Drug Development, GCP, GVP, GLP and regulatory compliance.

Skills

• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
• Very experienced in Quality Council Management.
• In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management.
• Understanding of BMS's therapeutic areas - HOCT and ICN.
• Extensive experience in regulatory inspection preparation, management, and related follow-up.
• Demonstrated analytical and conceptual capability, including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data.
• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
• Communication skills: communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for peer and Senior Management communication.
• Project management: able to manage complex assignments/projects and deliver all expected deliverables in a timely manner and proactively communicate changes in goals and deadlines.
• Ability to consider global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies.
• Resourceful and adaptable to changing business conditions, proactively seeking ways the organization can adapt its plans, tactics, or strategies.
• Fosters a culture of continuous improvement in services and processes.

Education

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience