Global PDM & Quality Compliance Specialist

Leiden Bio Science Park; Netherlands; On-site; EUR 70,000 - 100,000; Full time

Job summary

Leiden Bio Science Park seeks a Specialist, Process & Data Management (PDM) Program Expert to shape quality processes and learning solutions across global R&D. You will translate regulatory requirements into compliant, practical implementations, supporting innovation throughout development lifecycles.

You will collaborate with R&D Quality, Therapeutic Areas, Regulatory Affairs and other functions to implement integrated processes, training, and qualification solutions, enabling efficient,

Qualifications

• Bachelor’s degree in Science, Business, or related field required.
• 1–3 years in a medium-to-large matrix organization in life sciences preferred.
• Experience with process design, training design, qualification management or related field.

Responsibilities

• Lead and contribute to ARR and Quality Framework Integration initiatives.
• Drive end-to-end process assessment, development, implementation and integration.
• Develop and maintain training and qualification materials within GxP framework.
• Collaborate with cross-functional teams to ensure compliant processes.
• Support changes, CAPAs, inspections, investigations and regulatory requests.

Education

Bachelor’s degree in Science, Business, or a related field

Tools

Microsoft Office Suite

Job description

Leiden Bio Science Park seeks a Specialist, Process & Data Management (PDM) Program Expert to shape quality processes and learning solutions across global R&D. You will translate regulatory requirements into compliant, practical implementations, supporting innovation throughout development lifecycles.

You will collaborate with R&D Quality, Therapeutic Areas, Regulatory Affairs and other functions to implement integrated processes, training, and qualification solutions, enabling efficient,