Associate Director, R&D Quality Governance

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Position 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.

Key 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 (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, trad