Director, Enterprise Digital & Technology Build Lead – GQRC

The Director, Global Quality, Regulatory & Clinicals (GQRC) is a technology leader responsible for defining and executing the technology strategy, roadmap, and delivery portfolio that supports regulated product development, compliance, quality operations, clinical execution, regulatory submissions, and labeling processes across Global Quality Operations (GQO). This role owns the end‑to‑end lifecycle of Product Lifecycle Management (PLM), Quality, Regulatory, Clinical, and Labeling technology platforms, ensuring solutions are scalable, secure, reliable, and aligned with business priorities.

This Director leads cross‑functional products, engineering, solution architecture, and delivery teams while partnering closely with R&D, Quality, Regulatory Affairs, Clinical, Labeling leaders. The role translates business needs into executable technology plans, drives process standardization, automation, and digital transformation, manage vendor and partner relationships, and strengthens operational performance.

Key responsibilities include:

• Define and execute a multi-year roadmap for PLM, Quality, Regulatory, Clinical, Product Labeling, and related GQRC platforms, ensuring alignment with business priorities, regulatory expectations, and enterprise architecture standards.
• Lead products, platforms, engineering, solution architects, and delivery teams supporting GQRC solutions across global and matrixed environments.
• Partner with senior leaders across R&D, Quality, Regulatory Affairs, Clinical, and Labeling to align technology investments with operational objectives and measurable business outcomes.
• Establish product and platform strategies that improve regulatory compliance, operational efficiency, quality, and business outcomes.
• Provide leadership for global technology deployments, including solution design, process alignment, integration strategy, validation readiness, change adoption, cutover planning, post‑go‑live stabilization, and value realization.
• Apply fit‑for‑purpose delivery methodologies, including Agile, SAFe, hybrid, and Waterfall approaches, to ensure governance, execution discipline, and delivery practices are matched to program complexity, regulatory needs, and business outcomes.
• Drive platform enhancements, integrations, upgrades, modernization, simplification, and continuous improvement across PLM, labeling, clinical, quality, regulatory, laboratory, and related regulated technology capabilities.
• Ensure platforms and solutions operate in alignment with enterprise architecture, cybersecurity, privacy, compliance, computer system validation, audit readiness, quality management system expectations, and applicable Med Tech requirements, including FDA and ISO standards.
• Govern prioritization, investment decisions, demand management, and delivery planning across the GQRC technology portfolio.
• Identify opportunities to simplify processes, automate workflows, standardize operations, and improve operational effectiveness through technology.
• Establish engineering, delivery, and platform management standards that improve quality, reliability, scalability, and speed of execution.
• Serve as a senior technology leader and trusted advisor for platforms such as PTC Windchill, Loftware Cloud, Track Wise, Lab Vantage, Medidata, and related enterprise solutions supporting product development and regulated operations.
• Manage strategic vendor, implementation partner, and consultant relationships, including selection, contracting support, performance oversight, issue resolution, and accountability for quality deliverables.
• Develop and monitor KPIs measuring platform adoption, operational performance, delivery effectiveness, system reliability, and value realization.
• Collaborate with Enterprise Architecture, Cybersecurity, Infrastructure, Data, Integration, Program Enablement, and Governance teams to ensure solutions are secure, supportable, integrated, and aligned with enterprise technology direction.
• Stay current on industry trends, regulatory expectations, and technology advancements, and apply those insights to improve the platform roadmap, delivery practices, operating model, and long‑term business value.

Qualifications &…