Quality & Data Management PDM Specialist

6010-Biosense Webster Inc. Legal Entity; Raritan (NJ); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson is seeking a Specialist, Process & Data Management (PDM) Program Expert to join the QM&D organization. You will translate regulatory and quality requirements into integrated processes, training materials, and qualification solutions across global R&D.

The role collaborates with Therapeutic Areas, Global Development, Medical Safety, Regulatory Affairs, and other quality functions.

Qualifications

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

Responsibilities

• Leading ARR (Adopting Regulatory Requirements) and Quality Framework Integration initiatives.
• Driving the assessment, analysis, development, implementation, and integration of compliant end-to-end processes.
• Developing and maintaining training and qualification materials within the GxP Quality Management Framework.
• Performing requirement comparison, assessment, and integration activities across the Quality Management System.
• Participating in content management and qualification transformation initiatives, including programs such as Aris CCL.
• Aligning business requirements, regulatory expectations, and Quality Management System processes.
• Contributing to activities associated with changes, CAPAs, inspections, investigations, and regulatory requests.
• Driving project activities related to timelines, deliverables, process design, training strategies, implementation, and maintenance.
• Managing assigned change management, risk management, issue resolution, and process analysis activities.
• Applying First-Time-Right principles to deliverables and program outputs.
• Providing project updates and communicating progress, risks, and resolutions to business owners and management.
• Advancing data-centric content and qualification management initiatives.
• Working closely with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality functions

Skills

Analytical Reasoning

Compliance Management

Process Optimization

Project Management

Quality Assurance

Quality Control

Training Administration

Data Reporting

Education

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

Tools

Microsoft Office

Job description

Johnson & Johnson is seeking a Specialist, Process & Data Management (PDM) Program Expert to join the QM&D organization. You will translate regulatory and quality requirements into integrated processes, training materials, and qualification solutions across global R&D.

The role collaborates with Therapeutic Areas, Global Development, Medical Safety, Regulatory Affairs, and other quality functions.