Global UDI PMO Lead: Strategy, Compliance & Delivery

Antler Co; West Chester (Chester County); On-site; USD 122,000 - 245,000; Full time

Job summary

Johnson & Johnson is seeking a Sr. Manager, UDI PMO to lead global governance, strategy, and execution of the UDI program across Raynham, MA and Ringaskiddy, Ireland.

This role focuses on regulatory compliance, data integrity, and scalable processes with cross‑functional visibility and impact on patient safety. The ideal candidate brings 8–10 years in regulated industries, strong leadership, and Deep knowledge of UDI regulations and quality systems.

Qualifications

• Bachelor's degree in Engineering, Information Systems, Life Sciences, Quality, or a related field.
• Master’s degree (MS, MBA) in a relevant discipline.

Responsibilities

• Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements (FDA, EU MDR, and other health authorities).
• Provide strategic oversight for UDI‑related technology initiatives, ensuring integration across ERP, labeling, master data, and regulatory submission systems.
• Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end‑to‑end UDI compliance and execution.
• Ensure inspection readiness by maintaining robust documentation, risk management, change control, and audit support processes.
• Lead and develop a team of PMO and UDI professionals, fostering accountability, continuous improvement, and strong quality culture.
• Monitor global regulatory changes related to UDI and assess business impact, driving timely implementation of required updates.
• Manage program risks, dependencies, and resource planning to ensure on‑time, compliant delivery of UDI initiatives.
• Drive process optimization and standardization using PMO best practices and quality system principles.

Skills

UDI PMO leadership

Regulatory compliance

Program management

Cross-functional leadership

Stakeholder influence

Quality systems

Education

Bachelor's in Engineering

Master’s degree

Job description

Johnson & Johnson is seeking a Sr. Manager, UDI PMO to lead global governance, strategy, and execution of the UDI program across Raynham, MA and Ringaskiddy, Ireland.

This role focuses on regulatory compliance, data integrity, and scalable processes with cross‑functional visibility and impact on patient safety. The ideal candidate brings 8–10 years in regulated industries, strong leadership, and Deep knowledge of UDI regulations and quality systems.