Senior Director, Global Regulatory Affairs & Clinical Safety (GRACS)Global Process Model Lead

Job Description

The GRACS Global Process Model Lead is primarily accountable and responsible for the overall governance and leadership of the GRACS Global Business Process Model, including managerial responsibilities for the GRACS Global Process Leads, leadership for the Global Process Lead Network, as well as defining the strategy and approach to optimize end-to-end processes and ensure consistency and standardization across regions and functional areas. This is accomplished through the utilization of internal and external resources to ensure GRACS has quality driven, efficient, inspection ready business processes, and well-trained staff, equipped to perform critical GRACS work. This position is a key contributor to the Business Continuity, Standards & Training Leadership team, and reports to the Head of BCST.

Primary activities/responsibilities

GRACS Global Process Management:

• Leads the transformation of GRACS Business Process Management capabilities, including developing and executing an integrated strategy for the continued evolution and effective management of the GRACS Global Process Lead Model. Champions continuous improvement to meet the evolving regulatory environment.   

• Provides overall leadership for the GRACS Business Process Model by working with Subject Matter Experts (SMEs) in the design, development, review, implementation and maintenance of business process maps, SOP’s, work instructions, guidelines and process maps to ensure compliance with regulatory requirements and our company's policies.

• Works with key leaders across the research divisions (i.e., GCD, GRACS, QA, GMSA, CORE, Ethics & Compliance, Legal, Privacy) and in other divisions to ensure Procedural alignment and compliance with connecting corporate or divisional standards.

• Leads assigned global business process forum(s), accountable for successful design and performance of multiple global business processes; Collaborates with various stakeholders, including leading cross-functional teams, to drive process improvements, streamline operations, and achieve business objectives on a global scale.

• Deep domain knowledge of the end-to-end process for their respective global business processes

• Accountable for ensuring comprehensive and expert input into decisions/changes that affect business processes, roles and responsibilities, and role-based training associated with core business processes.

• Partners with Business System Owners (BSO) on alignment of process & technology to enable processes.

• Works with the research divisions’ Quality Forum and global functions to address process, competency, and verification gaps that impact ability to be efficient while maintaining acceptable “compliance” and quality to ensure inspection readiness for core global GRACS business processes.

• Establishes and directs dedicated resources to optimize operational quality in key process areas by identifying tools, systems, and processes for improvement.

• Responsible for alignment cross-functionally outside of GRACS and throughout the company to develop and improve enterprise-wide process optimization.

• Accountable for engaging with various stakeholders, including senior management, department heads, and cross-functional teams. Understands requirements, collaborates with them to develop solutions, address concerns, and ensures alignment with the overall business strategy.

• Develops strategy and approach to establish key performance indicators (KPIs) and metrics to measure the effectiveness of global processes. Regularly monitor and track performance against these metrics to identify deviations or areas needing improvement. Prepare reports and present findings to management, highlighting achievements, challenges, and proposed actions.

• Proactively identifies and addresses process-related risks, establish control mechanisms, and ensure adherence to regulatory guidelines.

• Drives and leads large-scale cross-functional/divisional change initiatives in alignment with the strategy, including cross-GRACS productivity initiatives to fortify our future; and

• Develops and delivers executive-level presentations that provide status updates and reflect progress against objectives and drive business decisions.

• Represents GRACS on pan-industry initiatives.

People Management & Capability Development:

• Designs and delivers targeted development capability sessions for the organization, including, but not limited to: Lean, Six Sigma, Project Management, Change Management

• Leads and manages GRACS Global Process Leads, accountable for providing leadership, guidance, and support to ensure their professi