GCM Medical Operations & Governance Lead

Job Description:

Responsibilities

• Lead the centralized Medical Operations & Governance team within the Bengaluru Global Capability Center GCC), delivering SOP & documentation governance, CAPA coordination, vendor management, grant reconciliation, and purchase order management for Medical Affairs
• Manage a mid-sized team providing operational governance and compliance services across Global Medical
• Establish and serve as site lead for the Bengaluru Medical GCC, building organizational capabilities, defining operating rhythms, and fostering a high-performance, compliant, and collaborative culture aligned with Global Medical priorities
• SOP & Documentation Governance:
• Lead end-to-end SOP and documentation governance across Medical activity domains, ensuring lifecycle processes are consistently applied, high-quality standards are maintained, and documentation remains inspection-ready across the Medical Governance Office portfolio and local GCM activities.
• Establish and continuously evolve Records Information Management (RIM), central documentation storage and archiving, templates, and governance controls — driving standardization, monitoring adherence, and ensuring effective management of deviations and controlled exceptions across Medical execution
• CAPA Coordination:
• Own oversight of CAPA processes across the Medical Governance Office, ensuring timely identification, tracking, and resolution of issues; implement governance mechanisms to monitor performance, enforce accountability, and maintain audit readiness
• Proactively assess CAPA trends and systemic risks, driving escalation where needed and partnering with stakeholders to strengthen root cause resolution and prevent recurrence
• Vendor Operations & Grant Management:
• Lead workflow design and lifecycle management of vendor operations and grant management processes in partnership with Procurement, Medical Business Operations, and Medical Governance Office, ensuring performance oversight, contractual compliance, and standardized execution across supplier base
• Oversee workflows in medical grant and sponsorship validation and reconciliation processes, ensuring alignment between approved terms, deliverables, and financial records; drive consistency and control in accordance with Takeda financial and compliance requirements
• Contract Operations and Procurement Support:
• Oversee GCM-based contract operations team, ensuring efficient PO workflows within Business Operations processes, payment integrity, and adherence to financial and operational governance standards
• Drive coordination with Business Operations, Finance, and Procurement to ensure accurate spend tracking, timely reconciliation, and continuous improvement of process efficiency and transparency
• Ensure robust vendor onboarding and documentation governance processes are in place, maintaining complete, compliant, and audit-ready operational records