Specialist, PDM Program Expert

6010-Biosense Webster Inc. Legal Entity; High Wycombe; On-site; GBP 60,000 - 90,000; Full time

Job summary

Johnson & Johnson in the United Kingdom seeks a Specialist, Process & Data Management (PDM) Program Expert to support QM&D. The role shapes regulatory-compliant processes, learning content, and qualification solutions across global R&D, coordinating with Regulatory Affairs and Medical Safety teams.

You will translate evolving requirements into practical, compliant solutions, drive end-to-end process design, and enable efficient R&D activities within a matrix organization.

Qualifications

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

Responsibilities

• Leading ARR and Quality Framework Integration initiatives.
• Developing and implementing compliant end-to-end processes.
• Creating and maintaining training and qualification materials within the GxP QMS.
• Performing requirement comparison and integration across the Quality Management System.
• Participating in content management and qualification transformation initiatives.
• Coordinating with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality.

Skills

Regulatory compliance knowledge

Global development collaboration

Process design

Training design

Quality Management System

Data-centric thinking

Communication skills

Attention to detail

Cross-functional teamwork

Education

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

Tools

Microsoft Office

Project management tools

Process mapping tools

AI concepts awareness

Job description

Job Description

We are searching for the best talent for a Specialist, Process & Data Management (PDM) Program Expert. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country's that align with your preferred location(s): Belgium, Netherlands - Requisition Number: R-100971 Switzerland - Requisition Number: R-101466 UK - Requisition Number: R-101468 US - Requisition Number: R-101472 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose

We are looking for a Specialist, Process & Data Management (PDM) Program Expert to join the Quality Management & Digital (QM&D) organization. Are you interested in helping shape how quality processes, qualification programs, and learning solutions are implemented across global R&D organizations? Are you energized by translating evolving regulatory requirements into practical, compliant solutions that support innovation? Quality Management & Digital (QM&D) is responsible for the Innovative Medicine Quality Management System (IMQS), GxP ownership, and global Quality Management processes. Within QM&D, the Process & Data Management (PDM) team works with partners across Therapeutic Areas, Global Development, Global Regulatory Affairs, Medical Safety, and R&D Quality to provide compliant process content and learning solutions that support business needs throughout the development lifecycle. In this role, you will contribute to improvement and compliance programs that require expertise across the GxP Quality Management System. Activities include Adopting Regulatory Requirements (ARR), Quality Framework integration, and strategic R&D Quality initiatives. The position evaluates, compares, maps, and integrates evolving regulatory and business requirements within the existing Quality Management System framework, helping ensure process, qualification, and training requirements are implemented effectively and compliantly. You will be responsible for This role contributes to compliance and improvement programs across the Quality Management System by translating regulatory, business, and quality requirements into integrated processes, training materials, and qualification solutions. Working with business owners, R&D Quality colleagues, and cross-functional teams, you will participate in process analysis, requirement integration, content management, qualification activities, and program execution. The role enables business partners to conduct R&D activities efficiently and in compliance with applicable requirements.

Responsibilities

Responsibilities include:

• Leading and contributing to 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

Qualifications / Requirements

• Education Bachelor’s degree in Science, Business, or a related field
• Experience Minimum 1–3 years of experience in a medium-to-large matrix organization
• Experience Minimum 1 year of experience in a pharmaceutical, medical device, healthcare, compliance, or related R&D environment
• Experience Minimum 1 year of experience in process design, training design, qualification management, or a related field
• Knowledge & Skills Knowledge of global pre-clinical and clinical compliance regulations and guidelines
• Knowledge & Skills Awareness of regulatory and legal requirements within the life sciences industry
• Knowledge & Skills Experience contributing to process improvement, procedural integration, and qualification activities
• Knowledge & Skills Ability to work effectively within tight timelines and changing priorities
• Knowledge & Skills Strong collaboration, networking, and relationship-building skills
• Knowledge & Skills Ability to operate effectively in a matrix and virtual environment
• Knowledge & Skills Business acumen and understanding of organizational priorities
• Knowledge & Skills Basic understanding of digital technologies and data-related capabilities
• Knowledge & Skills Strong written and verbal communication skills
• Knowledge & Skills Attention to detail, adaptability, and execution focus
• Knowledge & Skills Ability to work effectively across functions and within team environments

Technology Skills

• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
• Experience using project management tools
• Experience with process mapping or value stream mapping tools is preferred
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

Leadership Capabilities

• Ability to build effective relationships with business partners
• Ability to contribute to an open and collaborative work environment
• Ability to work effectively with diverse teams and perspectives
• Ability to influence and align stakeholders within a matrix organization

What we offer

We offer an environment where learning, innovation, and professional development are encouraged. This role provides opportunities to work across R&D Quality, Clinical Development, Medical Safety, Regulatory Affairs, and other global functions while contributing to process excellence, Quality Management System evolution, and strategic transformation initiatives. Join us and help shape the future of quality, process management, and learning solutions!

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives. We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds. If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

Required Skills: Preferred Skills

Analytical Reasoning, Business Behavior, Business Savvy, Compliance Management, Continuous Improvement, Continuous Quality Improvement (CQI), Data Reporting, Goal Attainment, Healthcare Facilities Management, Problem Solving, Process Optimization, Project Management, Quality Assurance (QA), Quality Control (QC), Quality Standards, Training Administration, Training Delivery Methods, Training Needs Analysis (TNA), Training People

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.