Qualified Person (QP) - Radiopharmaceuticals

About the role

Novartis is looking for a Qualified Person (QP) in Baarle-Nassau, The Netherlands. The QP is responsible for batch release, ensuring product quality and compliance with cGMP, Dutch legislation and European pharmaceutical regulations, and oversees the quality system and the timely release of radiopharmaceutical products. Relocation support is not offered.

Key responsibilities

• Release batch analysis in line with EU Directive 2001/83/EC and national regulations, and partner with Supply Chain to support reliable product supply.
• Provide quality, compliance and technical expertise so that deviations, CAPAs, change controls and quality complaints are investigated and managed, with safety-impacting issues escalated and resolved.
• Oversee site operations, including validation and qualification status, equipment, personnel training and quality management system activities.
• Write, review and approve GMP documentation such as procedures, work instructions, protocols, reports and Quality Manual updates.
• Act as Subject Matter Expert for quality processes during health authority, internal and external audits.
• Support a strong quality culture through collaboration, coaching, cGMP training, shift or on-call support, and deputize for the Quality Operations Manager when needed.

Required profile

• Master's degree in a scientific discipline; pharmacy is preferred.
• 3+ years of experience in a similar role or in a Quality Assurance position in pharma or biotechnology.
• Fluent English, written and spoken.
• Hands-on, proactive style with an agile approach to priorities and continuous improvement.

Required skills

• Strong knowledge of GMP requirements and applicable pharmaceutical regulations.
• Ability to take ownership and drive tasks forward.

What we offer

• Base salary range of EUR 56,100 - 104,300, with a possible performance-based bonus.
• Insurance plans, retirement plans, wellbeing resources and global recognition programmes.
• Flexible and hybrid working where possible, and at least 14 weeks of paid parental leave.