Global UDI PMO Lead — Regulatory & Quality Impact

Brighter Signals; Loughbeg; Presencial; EUR 85.000 - 146.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Descripción de la vacante

Johnson & Johnson is seeking a Sr Manager, UDI PMO in Ireland (Cork or Dublin) to lead the strategic planning, governance, and execution of the UDI program across global regulatory requirements.

You will partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end-to-end compliance, maintain inspection readiness, manage risks, and develop a high-performing PMO team in a cross-functional, matrixed environment. Travel up to 25% may be required.

Formación

• Bachelor’s degree in Engineering is required; Master’s degree (MS, MBA) preferred.
• 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry.
• Demonstrated leadership of complex, cross‑functional programs with global scope.
• Strong knowledge of UDI regulations and quality system requirements.
• Experience working with enterprise systems (ERP, labeling, master data, regulatory systems).
• Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.

Responsabilidades

• Lead the UDI PMO with governance, roadmaps, milestones, and 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.

Conocimientos

Agile Decision Making

Cross-Functional Collaboration

Leadership

Project Management

PMO

Regulatory Knowledge

Educación

Bachelor's degree in Engineering

Master's degree (MS, MBA)

Herramientas

ERP systems

Regulatory systems

Labeling systems

Master data management

Descripción del empleo

Johnson & Johnson is seeking a Sr Manager, UDI PMO in Ireland (Cork or Dublin) to lead the strategic planning, governance, and execution of the UDI program across global regulatory requirements.

You will partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end-to-end compliance, maintain inspection readiness, manage risks, and develop a high-performing PMO team in a cross-functional, matrixed environment. Travel up to 25% may be required.