Specialist, PDM Program Expert

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Well-being programs

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a Specialist, Process & Data Management to join the QM&D organization. You will translate regulatory and business needs into integrated processes, training materials, and qualification solutions across global R&D teams.

In this role, you’ll collaborate with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality to drive compliant process improvement and data-centric content.

Qualifications

• Knowledge of global pre-clinical and clinical compliance regulations.
• Awareness of regulatory and legal requirements within life sciences.
• Experience contributing to process improvement and qualification activities.
• Ability to work effectively in a matrix and virtual environment.

Responsabilités

• Lead ARR and Quality Framework Integration initiatives.
• Develop and implement compliant end-to-end processes.
• Create and maintain training and qualification materials within the GxP QM framework.
• Perform requirement assessment and integration across the QMS.
• Coordinate content management and qualification transformation initiatives.

Connaissances

Analytical reasoning

Business behavior

Business savvy

Compliance management

Continuous improvement

CQI

Data reporting

Goal attainment

Problem solving

Process optimization

Project management

Quality assurance

Quality control

Quality standards

Training administration

Training delivery methods

Training needs analysis

Training people

Formation

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

Outils

Project management tools

Process mapping tools

AI concepts and frameworks awareness

Description du poste

Job Function:

Quality

Job Sub Function:

Quality Training

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Breda, Netherlands

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

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

The anticipated pay range for this position, in the primary posting location, is:

€60000,00 - €96255,00

The anticipated pay ranges for additional locations are:

[Netherlands] – The anticipated base pay range for this position is [EUR 53,500.00] – [EUR 85,445.00]

Benefits

• In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.