Quality Specialist - Clinical QP

Our client, a leading life sciences organization, is seeking a specialist to assess and enhance a quality management system in alignment with EU GMP requirements. The role supports inspection readiness and a manufacturing import authorization project to enable compliant processes for clinical product certification.

• Review and assess the current quality management system, including policies, SOPs, and quality records.
• Evaluate system alignment with applicable EU GMP requirements for clinical trial manufacturing and importation.
• Identify regulatory, procedural, and implementation gaps to define risk-based priorities for remediation.
• Lead the Manufacturing Import Authorization (MIA) project as a quality subject matter expert.
• Support preparation for Health Authority inspections and ensure readiness of critical systems such as deviation management and CAPA.
• Collaborate with stakeholders to align processes for clinical product certification.

• You have 8+ years of relevant experience in pharmaceutical quality assurance and quality management.
• You bring extensive expertise in setting up a QMS and managing Manufacturing Import Authorization (MIA) license requests.
• You possess expert knowledge of EU GMP requirements (including Annex 16 and Annex 21) and regulatory frameworks for clinical trials such as Regulation (EU) No 536/2014.
• You have experience managing quality systems including batch documentation, supplier oversight, CAPA, and change control.
• You're a collaborative professional with a pragmatic, inspection-focused approach to problem-solving.
• You are fluent in English.

Nice to Haves

• Possession of a Qualified Person certification.
• Active knowledge of Dutch or French.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.