Quality Process & Data Management Specialist

Johnson Johnson; United States; On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

401(k) plan

Pension

Long-term incentive program

Paid time off

Job summary

Johnson & Johnson is seeking 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 units.

You'll collaborate with Therapeutic Areas, Global Development, Medical Safety, Regulatory Affairs, and R&D Quality to drive compliant end-to-end processes and enable efficient,

Qualifications

• Bachelor’s degree in Science, Business, or related field.
• 1–3 years of experience in a medium-to-large matrix organization.
• 1 year of experience in a pharmaceutical, medical device, healthcare, compliance, or related R&D environment.
• Experience in process design, training design, qualification management, or related field.

Responsibilities

• Lead ARR and Quality Framework Integration initiatives.
• Drive end-to-end process assessment, development, implementation, and integration of compliant processes.
• Develop and maintain training and qualification materials within the GxP Quality Management Framework.
• Perform requirement comparison, assessment, and integration across the Quality Management System.
• Participate in content management and qualification transformation initiatives, including Aris CCL.
• Align business requirements, regulatory expectations, and Quality Management System processes.
• Contribute to changes, CAPAs, inspections, investigations, and regulatory requests.
• Drive project activities, timelines, deliverables, process design, training strategies, and maintenance.

Skills

Quality Management System

Process design

Training design

Qualification management

Regulatory compliance

Cross-functional collaboration

Project management

Data management

GxP Knowledge

Learning solutions

Education

Bachelor’s degree in Science, Business, or related field

Tools

Microsoft Office

Project management tools

Process mapping tools

Aris CCL

Job description

Johnson & Johnson is seeking 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 units.

You'll collaborate with Therapeutic Areas, Global Development, Medical Safety, Regulatory Affairs, and R&D Quality to drive compliant end-to-end processes and enable efficient,