Hybrid: Global UDI PMO Lead

Biopharma Careers; Cork; Hybrid; EUR 85,000 - 146,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson in Cork, Ireland, seeks Sr Manager, UDI PMO to lead the global Unique Device Identifier program across REG/QA and IT interfaces. You will set governance, roadmaps, and milestones, ensuring regulatory compliance and audit readiness while enabling scalable UDI processes across ERP, labeling, and master data.

You will manage a PMO team, drive cross-functional execution with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial units, and monitor regulatory changes to

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field is required.
• Master’s degree (MS, MBA) in a relevant discipline is preferred.
• 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry (medical device preferred).
• Demonstrated leadership of complex, cross‑functional programs with global scope.

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 system.
• 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

Leadership

Cross-functional collaboration

PMO leadership

Regulatory knowledge

Stakeholder influence

Education

Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field

Master’s degree (MS, MBA) in a relevant discipline

Tools

ERP systems

Labeling systems

Master data systems

Regulatory submission systems

Job description

Johnson & Johnson in Cork, Ireland, seeks Sr Manager, UDI PMO to lead the global Unique Device Identifier program across REG/QA and IT interfaces. You will set governance, roadmaps, and milestones, ensuring regulatory compliance and audit readiness while enabling scalable UDI processes across ERP, labeling, and master data.

You will manage a PMO team, drive cross-functional execution with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial units, and monitor regulatory changes to