PDM & Quality Excellence Specialist

Johnson & Johnson Innovative Medicine; Hopewell Township (OH); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson Innovative Medicine seeks a Specialist, Process & Data Management (PDM) Program Expert to join the Quality Management & Digital (QM&D) organization. The role focuses on translating regulatory and business requirements into compliant processes, training materials, and qualification solutions across global R&D teams.

You will work with Therapeutic Areas and Global Development to drive ARR and Quality Framework integrations, design end-to-end processes, and deliver training

Qualifications

• Knowledge of global pre-clinical and clinical compliance regulations.
• Experience in process design, training design, qualification management, or related field.
• Ability to translate regulatory requirements into actionable learning content.
• Experience in working in a matrix organization.

Responsibilities

• Translate regulatory, business, and quality requirements into integrated processes.
• Collaborate with cross-functional teams to implement training and qualification solutions.
• Lead and support ARR and Quality Framework integration initiatives.
• Manage timelines, deliverables, and change management activities.
• Support inspections and regulatory requests as needed.

Skills

Quality Mgmt

Regulatory knowledge

Process improvement

Cross-functional collab

Project management

Data analysis

Education

Bachelor’s degree in Science/Business/related field

Tools

Microsoft Office

Project management tools

Process mapping tools

AI concepts awareness

Job description

Johnson & Johnson Innovative Medicine seeks a Specialist, Process & Data Management (PDM) Program Expert to join the Quality Management & Digital (QM&D) organization. The role focuses on translating regulatory and business requirements into compliant processes, training materials, and qualification solutions across global R&D teams.

You will work with Therapeutic Areas and Global Development to drive ARR and Quality Framework integrations, design end-to-end processes, and deliver training