Specialist, PDM Program Expert

jj

High Wycombe

Hybrid

GBP 65,000 - 90,000

Full time

6 days ago

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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 and QA functions.

You will work with cross-functional partners to drive ARR, Quality Framework integration, and data-centric content initiatives, ensuring compliance and timely delivery

Qualifications

Quality Management System knowledge and experience in life sciences.
Experience in pharmaceutical/medical device/R&D environments.
Ability to work in a matrix and virtual environment.
Strong written and verbal communication skills.
Attention to detail and execution focus.

Responsibilities

Lead ARR and Quality Framework Integration initiatives.
Drive end-to-end process assessment, development, and integration of compliant processes.
Develop and maintain training and qualification materials within the GxP framework.
Coordinate content management and qualification transformation initiatives.
Collaborate with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality.

Skills

Quality Management

Cross-functional collaboration

Data management

Regulatory awareness

Project management

Education

Bachelor’s degree in Science/Business/related field

Tools

Microsoft Office

Project management tools

Process mapping tools

Job description

Job Function: Quality

Job Sub Function: Quality Training

Job Category: Professional

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

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 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

We are looking for someone who combines Quality Management System knowledge, strong collaboration skills, and an interest in process excellence and quality management.

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
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

Knowledge & Skills

Knowledge of global pre-clinical and clinical compliance regulations and guidelines
Awareness of regulatory and legal requirements within the life sciences industry
Experience contributing to process improvement, procedural integration, and qualification activities
Ability to work effectively within tight timelines and changing priorities
Strong collaboration, networking, and relationship-building skills
Ability to operate effectively in a matrix and virtual environment
Business acumen and understanding of organizational priorities
Basic understanding of digital technologies and data-related capabilities
Strong written and verbal communication skills
Attention to detail, adaptability, and execution focus
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.

#LI-Hybrid

Preferred Skills