Specialist, PDM Program Expert

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

We are looking for someone who combines Quality Management System knowledge, strong collaboration skills, and an interest in process excellence and quality management.

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