Specialist, PDM Program Expert

6010-Biosense Webster Inc. Legal Entity; Allschwil; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Allschwil, Switzerland, is seeking a Specialist, Process & Data Management (PDM) Program Expert to join the Quality Management & Digital (QM&D) organization. You will help shape how quality processes, qualification programs, and learning solutions are implemented across global R&D, translating evolving regulatory requirements into practical, compliant solutions.

Work across Therapeutic Areas, Global Development, Medical Safety, and Regulatory Affairs to deliver end-to-end

Qualifikationen

• Bachelor’s degree in science, business, or related field is required.
• 1–3 years in a medium-to-large matrix organization and 1 year in pharma/healthcare R&D environment.
• Experience designing processes, training, and qualification management.
• Knowledge of global pre-clinical and clinical compliance regulations.

Aufgaben

• Lead ARR and Quality Framework Integration initiatives.
• Assess, develop, implement, and integrate compliant end-to-end processes.
• Develop and maintain training and qualification materials within GxP.
• Contribute to changes, CAPAs, inspections, and regulatory requests.
• Partner with Therapeutic Areas and Regulatory Affairs to align requirements.

Kenntnisse

Analytical Reasoning

Process Optimization

Project Management

Training Administration

Training Delivery Methods

Data Reporting

Communication Skills

Ausbildung

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

Tools

Microsoft Office

Project management tools

Process mapping tools

AI concepts awareness

Jobbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 jnj.com.

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.

Job Function: Quality

Job Sub Function: Quality

Training Job Category: Professional

All Job Posting Locations: Allschwil, Switzerland

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.

Responsibilities

• 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
• 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, 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

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

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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/.