Risk

• 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 (e.g. E8, E6, E9, Q9) and other relevant regulatory requirements.
• Other Drive continuous improvement initiatives to enhance quality processes and systems. Develop and deliver training programs to enhance quality awareness and competencies across the organization. Provide leadership, guidance, development and coaching for management of significant quality issues. Establish strong partnerships with business stakeholders. External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers. Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation. Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level. Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline. Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department. Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to indirect reports/peers within the organization. May influence the external environment through interactions with regulators, trade associations, or professional societies. Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

Associate Director, R&D Quality Governance

Senior Business Control Specialist – QC Risk Governance

Senior Director of Risk

Director, Asset Management Risk

Data Governance & Data Domain Architect, VP

VP, Operational Risk and Resilience – Risk and Enablement