Quality Systems Lead

ProPharma provides advice and expertise that empowers biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies. The company partners with clients across the complete product lifecycle, with expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology.

Role Overview

Experienced QA leader responsible for end-to-end quality systems oversight and process validation. Ensures compliance with GMP/GDP/GVP regulations and drives (e)QMS excellence. A successful candidate combines strong technical expertise with excellent collaboration, communication, and stakeholder engagement skills. Fosters quality culture and continuous improvement by building strong cross-functional relationships, providing clear guidance, and fostering alignment across teams.

Key Responsibilities

• Act as QA lead, ensuring compliance with GMP, GDP, GVP, and global regulatory standards
• Own and optimize the (e)QMS, ensuring robust documentation, traceability, and archiving
• Manage quality events, including deviations, CAPAs, change controls, and complaints, ensuring timely resolution
• Perform gap assessments and enhance validation and qualification strategies (DQ/IQ/OQ/PQ, cleaning, transport) using risk-based and lifecycle approaches (e.g., CPV, FMEA)
• Coordinate training activities and maintain high standards of procedures and documentation
• Collaborate cross-functionally with internal and external stakeholders to maintain quality standards
• Drive operational efficiency and continuous improvement initiatives
• Oversee GDPR compliance and manage non-GxP document repositories

Experience & Qualifications

• 5+ years in QA, QMS, or validation roles within pharma/biotech
• Bachelor’s degree in Life Sciences or equivalent
• Strong expertise in GMP and global regulatory frameworks
• Strong expertise in process validation lifecycle and continuous process verification
• Strong expertise in QMS implementation and event management
• Strong expertise in inspection readiness and audits
• Strong expertise in risk management methodologies (e.g., FMEA)
• Strong communication, stakeholder management, and project management skills
• Proactive, solution-oriented, and effective in a matrix environment

Additional Information

• 12-month contract (extension likely)
• Preferably based in the Netherlands (Leiden area), with occasional on-site presence

Whilst ProPharma supports remote working, it also recognises the value that comes from in person collaboration. New hires based within a reasonably short commute of one of the offices are encouraged to work on a hybrid basis and spend some time working from that office location, as agreed with their manager.