Specialist, PDM Program Expert

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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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

• Bachelors degree in Science Business or a related field

Experience

• Minimum 13 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

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