Sr. Manager, UDI PMO

Key Responsibilities

• Lead the UDI Program Management Office (PMO)establishinggovernance roadmaps milestones and performance metrics aligned to global regulatory requirements (FDA EU MDR and other health authorities).

• Provide strategic oversight forUDIrelatedtechnology initiatives ensuring integration across ERP labeling master data and regulatory submission systems.

• Partner with Quality Regulatory Affairs Supply Chain IT and Commercial teams to driveendtoendUDI compliance and execution.

• Ensureinspectionreadiness bymaintainingrobust 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 drivingtimelyimplementation of required updates.

• Manage program risks dependencies and resource planning to ensureontime compliant delivery of UDI initiatives.

• Drive process optimization and standardization using PMO best practices and quality system principles.

Qualifications

Education:

• Required:Bachelors degree in Engineering Information Systems Life Sciences Quality ora relatedfield.

• Preferred: Masters degree (MS MBA) in a relevant discipline.
  

Experience and Skills:

Required:

• Typically810 years of progressive experience in Quality Regulatory Technology or Program Management within a regulated industry (medical device preferred).

• Demonstrated leadership of complexcrossfunctionalprograms with global scope.

• Strong knowledge of UDI regulations and quality system requirements.

• Experience working with enterprise systems (ERP labeling master data regulatorysystems).

• Proven ability to lead teams influence stakeholders and drive execution in a matrixed environment.
  

Preferred:

• Experience supporting regulatory inspections and healthauthorityaudits related to UDI or data integrity.

• PMO leadership experience within Technology Quality or QA organizations.

• Familiarity with EU MDR FDA UDI and global device registration frameworks.

• Experience driving process improvement initiatives (Lean Six Sigma).

• Background in medical devicemanufacturing ororthopedic products.

• Excellent communication risk management anddecisionmakingskills.

Other:

• Language: English (required).

• Travel:Limiteddomestic and occasional international.

• Certifications (Preferred): PMPPgMP Lean Six Sigma or equivalent.

For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

#DePuySynthesCareers