Sr. Manager, UDI PMO

Johnson & Johnson Innovative Medicine•Warsaw, IN

1d•$122,000 - $245,000•Hybrid

About The Position

The Sr. Manager, UDI PMO leads the strategic planning, governance, and execution of the Unique Device Identification (UDI) program. This role is critical to ensuring global regulatory compliance, data integrity, and sustained inspection readiness while enabling efficient, scalable UDI processes across systems and business partners. The role offers high visibility, cross‑functional leadership, and the opportunity to directly impact patient safety and regulatory outcomes across the DePuy Synthes portfolio.

Requirements

Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or a related field.
Typically 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.
English (required).

Nice To Haves

Master’s degree (MS, MBA) in a relevant discipline.
Experience supporting regulatory inspections and health authority audits 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 device manufacturing or orthopedic products.
Excellent communication, risk management, and decision‑making skills.
PMP, PgMP, Lean Six Sigma, or equivalent certifications.

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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (varies by state)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year