Director, PV Global Process Lead (GPL)

Role Summary

The Director, PV Global Process Lead (GPL) will design, optimize, and oversee core pharmacovigilance processes, including ICSR management, signal management, safety aggregate reporting, risk management, and the PV System Master File. Partnering with Global Process Owners, the GPL will define and deliver strategies and roadmaps that align with business priorities, regulatory requirements, and inspection readiness. By leading Communities of Practice and driving cross-functional collaboration, the GPL will embed best practices, foster continuous improvement, and reinforce the organization's position as a leader in Patient Safety.

Responsibilities

• Lead the design, optimization, and oversight of core PV processes within your assigned L2 pillar, ensuring effectiveness, inspection readiness, and alignment with regulatory requirements, industry best practice, and business priorities.
• Partner with Global Process Owners (GPOs) to define and deliver process strategies and roadmaps, ensuring cross-functional alignment and visibility of downstream impacts.
• Serve as the principal subject matter expert for assigned processes, engaging with Local Markets, governance bodies, and stakeholders to maintain consistent, non-siloed process oversight.
• Lead and actively engage Communities of Practice, fostering knowledge sharing, capability building, and adoption of good practices
• Drive metric-based demand and capacity planning, using benchmarking, KPIs, and other tools to inform decisions and prioritization.
• Lead Policy Evaluation and Regulatory Landscape (PEARL) assessments for assigned processes and oversee implementation of resulting changes.
• Define, monitor, and report on process health metrics (e.g., cycle times, efficiency, productivity) to drive continuous improvement and accountability.
• Map processes in designated process mapping tools to ensure accuracy, usability, and alignment with procedural documentation.
• Author and maintain assigned procedural documents and PV System Master File sections; collaborate with Enterprise Learning to assess training impact and ensure operational integration.
• Partner with Business Capability Enablement (BCE) and Strategy & Operations teams to deliver process improvement initiatives, tools, and technology enhancements.
• Represent the organization externally through contributions to industry working groups, benchmarking forums, and conferences to influence best practice and policy.

Qualifications

• Bachelor's degree or equivalent experience; advanced degree preferred.
• Extensive PV experience across core PV processes.
• Proven track record of end-to-end process ownership, including design, mapping (e.g., Adonis), optimization, and governance.
• Skilled in authoring and maintaining procedural documents.
• Demonstrated experience in regulatory inspection readiness, participation, and follow-up.
• Experience leading cross-functional governance, Communities of Practice, and external engagement with industry working groups.
• Strong background in KPI measurement, benchmarking, and process monitoring.

Skills

• Strategic process leadership with deep regulatory and technical expertise.
• Skilled collaborator and influencer across global, matrixed organizations, able to work effectively with GPOs, GPLs, and Local Markets.
• Strong analytical skills; able to use data to drive prioritization and decision making.
• Clear, concise communicator with the ability to engage senior stakeholders and diverse audiences.
• Change leader with a continuous improvement mindset; able to embed innovation and manage complexity.
• Resilient, adaptable, and culturally aware with a global mindset.

Education

• Bachelor's degree or equivalent experience; advanced degree preferred.

Additional Requirements

• Travel Required: Limited travel (up to 5%) to support continuous improvement initiatives, process reviews, training and team meetings.