• Overseeing and standardizing RBQM monitoring and risk review strategies at a program/portfolio level. • Facilitating the completion of Risk Assessment and Categorization Tools (RACT) with cross-functional leads. • Defining custom monitoring strategies for individual studies based on scope and risk evaluations. • Leading discussions with internal teams and sponsors to gain consensus on monitoring strategies and mitigations. • Providing ongoing oversight for identifying and mitigating emerging risks throughout the trial lifecycle. • Developing monitoring strategies and providing budget inputs for proposals and business development.

• Responsible for assisting in the development and execution of strategic risk initiatives. • Support risk strategies and frameworks around AI and other emerging technologies. • Maintain the Bank’s AI governance framework, including policies, standards, and controls. • Collaborate with business leaders, risk partners and the AI Transformation office on the development tools and processes. • Monitor trends to identify risks around emerging technologies and financial products and services. • Develop, implement and lead an enterprise wide scenario planning program around emerging risks. • Assist in the development of enterprise-wide risk strategies aligned with corporate strategic objectives.

Role Description The Director, Clinical Quality Risk & Portfolio Oversight leads enterprise-wide quality intelligence, portfolio risk surveillance, and centralized quality oversight activities across Clinical Development. This role is responsible for identifying emerging quality signals, systemic compliance risks, and operational trends across studies, vendors, computerized systems, audits, inspections, deviations, CAPAs, and quality metrics. Through data-driven analytics and risk-based oversight, the position enables a shift from study-level quality management to proactive, enterprise-wide quality risk management. This position serves as a strategic quality governance and quality analytics leader, partnering closely with other QA functions (including GLP and PV), functional Expertise Areas, Digital/Systems teams, and Functional Leadership. The role leads a team responsible for vendor quality oversight and clinical systems quality governance to drive standardized, risk-based oversight frameworks that enhance vendor performance management, system compliance, and overall quality across R&D. The role plays a critical part in strengthening a proactive, portfolio-wide quality model by leveraging trend analysis, risk insights, and centralized oversight to enhance compliance, inspection readiness, and operational effectiveness. This position is open to remote working. Key Responsibilities - Portfolio Quality Risk Surveillance - Lead enterprise-level quality surveillance activities across the clinical development portfolio. - Identify systemic quality risks, recurring compliance signals, and emerging operational vulnerabilities that may not be visible at the individual study level. - Analyze data from audits, inspections, CAPAs, deviations, site and central monitoring activities, vendor oversight, and quality metrics to identify trends and risk patterns. - Establish and maintain proactive quality risk detection, escalation, and mitigation frameworks. - Quality Analytics & Trend Management - Develop and maintain portfolio-level dashboards, analytics, and governance reporting to support quality oversight and leadership visibility. - Use data analytics to drive trend analysis across studies, functions, vendors, and systems to identify systemic/enterprise compliance concerns, opportunities for improvement, and emerging risks. - Translate complex quality data into actionable insights and recommendations for leadership. - Define and maintain meaningful risk indicators, thresholds, and escalation criteria. - Vendor Quality Oversight Leadership - Leads strategic oversight of clinical vendor quality management and establishes scalable oversight frameworks to enable broader application across Research and Development, including pre-clinical (GLP) and post-market (PV) domains. - Monitor CRO and third-party performance trends to identify systemic or recurring quality and compliance concerns. - Ensure risk-based oversight frameworks are implemented for CROs, laboratories, technology providers, and key service partners. - Drive consistency in vendor quality governance and risk management approaches. - Clinical Systems Quality Oversight - Provide leadership and oversight for clinical systems quality governance. - Ensure quality and compliance requirements are incorporated into clinical technology platforms and system lifecycle activities. - Partner with IT, Validation, and Operational stakeholders to assess and manage system-related quality risks and controls. - Oversee risk evaluation and trend analysis associated with computerized systems supporting GCP study related activities. - Develops quality oversight framework that will ensure GLP and PV system governance. - Enterprise Risk Management & Governance - Maintain and evolve a centralized risk repository that tracks high-level threats to the global clinical pipeline. - Partner with inspection readiness and QA leadership teams to identify enterprise risk areas requiring proactive mitigation. - Convert complex data into executive-level risk summaries and recommendations to support strategic decision-making. - Represent Clinical Quality in executive steering committees to ensure quality trends are factored into high-level business decisions. - Collaborates with risk management and governance bodies across GLP and PV R&D activities. - Organizational Leadership - Directly manage and develop: - Vendor Quality Oversight Lead - Clinical Systems Quality Lead - Build scalable quality surveillance, analytics, and governance capabilities across the organization. - Drive a culture of proactive risk identification and data-driven quality management. - Provide strategic leadership within the Clinical Quality organization. Qualifications - Bachelor’s degree in Life Sciences or related field required - Advanced degree preferred - Professional training or certification in risk management, quality systems, or data analytics preferred - Minimum of 10 years of experience in GCP Quality Assurance, Clinical Quality, Clinical Operations, or related GCP-focused roles within the pharmaceutical, biotechnology, or CRO industry - Demonstrated experience leading enterprise-level quality oversight and portfolio risk surveillance, including the design and implementation of risk-based quality management frameworks and governance models - Strong proficiency in quality metrics, dashboards, and analytics, with the ability to interpret complex data and compliance signals to identify systemic risks, emerging trends, and opportunities for proactive action - Strategic thinker with strong analytical and problem-solving skills, capable of translating risk insights into actionable recommendations and executive-level reporting - Strong leadership, communication, and stakeholder management skills, with the ability to influence across all organizational levels and partner effectively with cross-functional teams, including Clinical Operations, Regulatory Affairs, Data Management, Digital/Systems, and external vendors - Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements Benefits - Comprehensive medical, dental, and vision coverage - Life and disability insurance - Lifestyle reimbursement program - Flexible spending and health savings accounts - 401(k) with a generous company match - Paid time off, wellness days, and holidays - Two company-wide recharge breaks - Generous family resources and leave

• Consolidate the executive view of the Products and Technology portfolio; • Track critical initiatives, risks, dependencies, deadlines, and impediments; • Create and maintain area performance indicator dashboards; • Prepare executive reports for the board, heads, and director-level forums for Products and Technology; • Monitor the Technology and Products budget: actuals, forecasts, variances, and projections; • Support contract management, vendors, consultancies, and bodyshops; • Monitor productivity, capacity, quality, and governance performance metrics; • Support the organization of ITIL processes: incidents, changes, problems, releases, and SLAs; • Manage action plans from audits, risks, vulnerabilities, and non-conformities; • Support and roll out the definition of criteria, templates, and team cadences; • Build analyses that help leadership decide: prioritize, pause, accelerate, escalate, or replan initiatives; • Act as a connection point between Products, Technology, GRC, Strategic Planning, Controllership, Procurement, Finance, HR, and business areas.