Specialist, PDM Program Expert

Johnson & Johnson Innovative Medicine • Horsham, PA

7d • $79,000 - $127,650 • Hybrid

About The Position

We are searching for the best talent for a Specialist, Process & Data Management (PDM) Program Expert. This role is available across multiple countries. The Specialist, Process & Data Management (PDM) Program Expert will join the Quality Management & Digital (QM&D) organization. This role contributes 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.

Requirements

• 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
• 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

Nice To Haves

• Experience with process mapping or value stream mapping tools is preferred

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level