Specialist, PDM Program Expert

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.comAs 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: QualityJob Sub Function: Quality TrainingJob Category:ProfessionalAll Job Posting Locations:Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of AmericaJob 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-100971Switzerland - Requisition Number: R-101466UK - Requisition Number: R-101468US - Requisition Number: R-101472Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.PurposeWe 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 forThis 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 initiativesDriving the assessment, analysis, development, implementation, and integration of compliant end-to-end processesDeveloping and maintaining training and qualification materials within the GxP Quality Management FrameworkPerforming requirement comparison, assessment, and integration activities across the Quality Management SystemParticipating in content management and qualification transformation initiatives, including programs such as Aris CCLAligning business requirements, regulatory expectations, and Quality Management System processesContributing to activities associated with changes, CAPAs, inspections, investigations, and regulatory requestsDriving project activities related to timelines, deliverables, process design, training strategies, implementation, and maintenanceManaging assigned change management, risk management, issue resolution, and process analysis activitiesApplying First-Time-Right principles to deliverables and program outputsProviding project updates and communicating progress, risks, and resolutions to business owners and managementAdvancing data-centric content and qualification management initiativesWorking closely with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality functionsQualifications / RequirementsWe are looking for someone who combines Quality Management System knowledge, strong collaboration skills, and an interest in process excellence and quality management.EducationBachelor’s degree in Science, Business, or a related fieldExperienceMinimum 1–3 years of experience in a medium-to-large matrix organizationMinimum 1 year of experience in a pharmaceutical, medical device, healthcare, compliance, or related R&D environmentMinimum 1 year of experience in process design, training design, qualification management, or a related fieldKnowledge & SkillsKnowledge of global pre-clinical and clinical compliance regulations and guidelinesAwareness of regulatory and legal requirements within the life sciences industryExperience contributing to process improvement, procedural integration, and qualification activitiesAbility to work effectively within tight timelines and changing prioritiesStrong collaboration, networking, and relationship-building skillsAbility to operate effectively in a matrix and virtual environmentBusiness acumen and understanding of organizational prioritiesBasic understanding of digital technologies and data-related capabilitiesStrong written and verbal communication skillsAttention to detail, adaptability, and execution focusAbility to work effectively across functions and within team environmentsTechnology SkillsProficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and OutlookExperience using project management toolsExperience with process mapping or value stream mapping tools is preferredDemonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivityLeadership CapabilitiesAbility to build effective relationships with business partnersAbility to contribute to an open and collaborative work environmentAbility to work effectively with diverse teams and perspectivesAbility to influence and align stakeholders within a matrix organizationWhat we offerWe 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 inclusionAt 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-HybridRequired 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 PeopleThe anticipated base pay range for this position is :$79 000,00 - $127 650,00Additional 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.Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:Vacation –120 hours per calendar yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Raritan, New Jersey, United States of America; Horsham, Pennsylvania, United States of America; Titusville, New Jersey, United States of AmericaType: Full timeRemote: Hybrid WorkPosted: 2026-09-24Country: United States of AmericaRequisition: R-101472Posting ID: 409663e7a828103fede2ea6482bb0000