Specialist, Process & Data Management (PDM) Program Expert

Location: High Wycombe, Buckinghamshire, United Kingdom; hybrid

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions within Johnson & Johnson's global healthcare organization.

What you will do

• Lead and contribute to Adopting Regulatory Requirements and Quality Framework Integration initiatives.
• Assess, design, develop, implement, and integrate compliant end-to-end processes across the Quality Management System.
• Develop and maintain GxP training, qualification, and process materials.
• Compare, map, and integrate regulatory, business, and quality requirements.
• Manage project timelines, deliverables, process design, training strategies, change management, risks, issues, and maintenance activities.
• Collaborate with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality teams.

Requirements

• Bachelor's degree in Science, Business, or a related field.
• 1–3 years of experience in a medium-to-large matrix organization.
• At least 1 year of experience in a pharmaceutical, medical device, healthcare, compliance, or related R&D environment.
• At least 1 year of experience in process design, training design, qualification management, or a related field.
• Knowledge of global pre-clinical and clinical compliance regulations, life sciences requirements, process improvement, and qualification activities.
• Proficiency with Microsoft Office, project management tools, and an understanding of AI concepts, responsible AI practices, and effective prompting techniques.

Nice to have

• Experience with process mapping or value stream mapping tools.
• Experience with content management and qualification transformation initiatives such as Aris CCL.

Culture & Benefits

• Learning, innovation, and professional development are encouraged.
• Opportunity to work across global R&D Quality, Clinical Development, Medical Safety, and Regulatory Affairs functions.
• Collaborative work with diverse teams in a matrix and virtual environment.
• Inclusive equal-opportunity workplace with reasonable accommodation support during recruitment and onboarding.