Global UDI PMO Lead - Regulatory & Quality Impact

Johnson & Johnson Co.; Bridgewater Township (NJ); Sur place; USD 122 000 - 213 000; Plein temps

Avantages offerts par ce poste

Vacation time

Sick time

Holiday pay

Parental leave

Volunteer leave

Military leave

401(k) plan

Résumé du poste

Johnson & Johnson is seeking a Sr Manager Global UDI PMO to lead governance, strategy, and execution of the Unique Device Identification program across global functions. This role emphasizes regulatory alignment, data integrity, and scalable processes within DePuy Synthes’ portfolio.

The position offers high visibility and cross-functional leadership, with responsibilities spanning regulatory readiness, partnerships with Quality, Regulatory, IT, and Supply Chain, and program risk management in a

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field is required.
• 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.
• 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.

Responsabilités

• 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.

Connaissances

UDI regulations

Program management

Cross-functional leadership

ERP integration

Regulatory affairs

Formation

Bachelor’s degree (Engineering / Info Systems / Life Sciences / Quality)

MS or MBA preferred

Outils

ERP systems

Regulatory systems

Description du poste

Johnson & Johnson is seeking a Sr Manager Global UDI PMO to lead governance, strategy, and execution of the Unique Device Identification program across global functions. This role emphasizes regulatory alignment, data integrity, and scalable processes within DePuy Synthes’ portfolio.

The position offers high visibility and cross-functional leadership, with responsibilities spanning regulatory readiness, partnerships with Quality, Regulatory, IT, and Supply Chain, and program risk management in a