Manager, Program and Process Excellence

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Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Manager, Program & Process Excellence to be based in Titusville, NJ or Horsham, PA.

The Manager, Program & Process Excellence manages and enables the development, implementation, monitoring, and assessment of North America risk management programs, including Risk Evaluation and Mitigation Strategies (REMS). This position partners with Risk Management Leads, and reports to the Director, US Risk Management Operations.

Day-to-day responsibilities:

Program Operations and Cross-Functional Enablement

• Manage, support, and enable operational execution of REMS program elements and modifications
• Coordinate and facilitate vendor and/or cross-functional Core Team governance, materials, decisions, and follow-through
• Serve as an operational partner to RMLs, RMALs, and cross-functional stakeholders
• Maintain program status visibility, including Key Performance Indicators (KPIs), and escalate risks/issues appropriately
• Support and/or lead Shared System REMS program development and operations as needed
• Support business planning, contracting, budgeting, and invoice approvals

Risk Management Reporting Compliance and Regulatory Support

• Lead, coordinate and/or contribute to REMS modifications, revisions, regulatory submissions, and FDA responses
• Manage timelines, documentation, inputs, and stakeholder reviews for REMS Assessment Reports
• Maintain compliant risk management program/REMS documentation, with the Risk Management Lead(s)
• Partner with vendors and cross-functional teams on effectiveness assessment activities

Process Excellence and Continuous Improvement

• Drive standardization and process improvements across Risk Management Programs
• Identify and implement technology, automation, and AI-enabled opportunities to improve efficiency and compliance
• Maintain and improve SOPs, Work Instructions, checklists, and electronic workflows

Quality, Compliance, and Readiness

• Maintain inspection-ready documentation and program records
• Manage or coordinate CAPAs, Quality Issues, and remediation activities, as needed
• Support audit and inspection readiness through document retrieval, response development, storyboarding, and implementation tracking

Qualifications

• Bachelor’s Degree, life sciences preferred
• At least 5 years of experience, of which 3 years in REMS, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Medical Writing, or similar; equivalent combination of advanced degree and less experience will be considered
• Project management and vendor management experience
• Strong written and verbal communication skills
• Knowledge and experience with FDA regulatory aspects of prescription drug development end-to-end.
• Experience with various types of US submissions including generics
• Familiar with risk management program operations, including call center, database development and management, and effectiveness assessment
• Familiar with regulatory aspects at various stages of development, from entry-into-man to post approval activities
• Experience or familiarity with clinical trial operations, pharmacovigilance operations, and/or New Drug Applications (NDAs) or Biologics License Applications (BLAs)
• Ability to influence within function, cross-functionally and globally

Other requirements

• Ability to travel domestically occasionally and internationally, up to 25%

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.

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