Specialist, Process & Data Management (PDM) Program Expert

Location: Hybrid role based in Allschwil, Switzerland; positions are also posted for Belgium, the Netherlands, the UK, and the US.

Company

Healthcare and MedTech organization developing innovative medicine, medical technologies, and quality solutions across the product development lifecycle.

What you will do

• Lead and contribute to Adopting Regulatory Requirements and Quality Framework Integration initiatives.
• Assess, design, implement, and integrate compliant end-to-end processes within the GxP Quality Management System.
• Develop and maintain training, qualification, and process content for R&D quality programs.
• Coordinate project timelines, deliverables, process design, training strategies, implementation, and maintenance.
• Manage change, risk, issue resolution, process analysis, CAPA, inspection, investigation, and regulatory request activities.
• Collaborate with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, R&D Quality, and business owners.

Requirements

• Bachelor’s degree in Science, Business, or a related field.
• 1–3 years of experience in a medium-to-large matrix organization.
• At least 1 year of experience in pharmaceutical, medical device, healthcare, compliance, or related R&D environments.
• At least 1 year of experience in process design, training design, qualification management, or a related field.
• Knowledge of global pre-clinical and clinical compliance regulations, life sciences requirements, process improvement, and qualification activities.
• Proficiency with Microsoft Office, project management tools, and an understanding of AI concepts, responsible AI practices, and effective prompting techniques.

Nice to have

• Experience with process mapping or value stream mapping tools.
• Experience with content management and qualification transformation programs such as Aris CCL.

Culture & Benefits

• Learning, innovation, and professional development are encouraged.
• Opportunity to work across global R&D Quality, Clinical Development, Medical Safety, Regulatory Affairs, and other functions.
• Inclusive and collaborative environment with diverse teams and perspectives.
• Hybrid working environment.