Specialist, PDM Program Expert
2 days ago
High Wycombe
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. We are looking for a Specialist, Process & Data Management (PDM) Program Expert to join the Quality Management & Digital (QM&D) organization. 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. 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. • 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 We are looking for someone who combines Quality Management System knowledge, strong collaboration skills, and an interest in process excellence and quality management. • 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, • 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, • 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, • 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 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. 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 • 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 #J-18808-Ljbffr
