Specialist, PDM Program Expert

6010-Biosense Webster Inc. Legal Entity; Raritan (NJ); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson is seeking a Specialist, Process & Data Management (PDM) Program Expert to join the QM&D organization. You will translate regulatory and quality requirements into integrated processes, training materials, and qualification solutions across global R&D.

The role collaborates with Therapeutic Areas, Global Development, Medical Safety, Regulatory Affairs, and other quality functions.

Qualifications

• Bachelor’s degree in Science, Business, or a related field.
• 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.

Responsibilities

• Leading 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

Skills

Analytical Reasoning

Compliance Management

Process Optimization

Project Management

Quality Assurance

Quality Control

Training Administration

Data Reporting

Education

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

Tools

Microsoft Office

Job description

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 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

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

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

• 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 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.

Required 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

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 base pay range for this position is :

$79 000,00 - $127 650,00

Additional Description for Pay Transparency:

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program.
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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/.

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