Summary
Location: Baarle-Nassau, The Netherlands.
This role is based in Baarle-Nassau, The Netherlands.. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
The Qualified Person is responsible for batch release, ensuring product quality and compliance with applicable regulatory requirements, including cGMP, Dutch legislation, and relevant European pharmaceutical regulations.
This role provides quality oversight of operational activities and ensures the effective implementation, monitoring, and maintenance of a GMP-compliant quality system. The Qualified Person is also responsible for supporting a reliable supply chain through the timely release of radiopharmaceutical products.
Key responsibilities include the review and release of batch analysis in accordance with applicable requirements, the relevant Marketing Authorisation, and European Union pharmaceutical legislation, including Directive 2001/83/EC for medicinal products for human use.
About the Role
Major accountabilities
- Responsible for the timely release of radiopharmaceutical products manufactured on site, partnering with Supply Chain to support reliable product supply.
- Release batch analysis in compliance with applicable requirements, including EU Directive 2001/83/EC and relevant national pharmaceutical regulations.
- Provide quality, compliance, and technical expertise to ensure deviations, CAPAs, change controls, and product quality complaints are investigated and managed appropriately.
- Ensure deviations and complaints with potential impact on patient safety or product supply are properly handled, escalated, and resolved.
- Provide quality oversight for site operations, including validation and qualification status, equipment, personnel training, and quality management system activities.
- Write, review, and approve GMP documentation, including procedures, work instructions, protocols, reports, and Quality Manual updates.
- Act as Subject Matter Expert for assigned quality processes during health authority inspections, internal audits, and external audits.
- Support a strong quality culture through collaboration, coaching, training on cGMP requirements, shift or on-call support, and deputizing for the Quality Operations Manager when required.
Obligatory Requirements:
- Master’s degree in a scientific discipline. Pharmacy is preferred.
- 3+ years of experience in a similar role or in a Quality Assurance position within the pharmaceutical or biotechnology industry.
- Strong knowledge of GMP requirements and applicable pharmaceutical regulations.
- Hands-on and proactive working style, with the ability to take ownership and drive tasks forward.
- Demonstrates an agile mindset by setting clear priorities, collaborating openly, and using feedback to drive continuous, step-by-step improvements, reflecting the core elements of Agile culture within the Dutch organization.
- Fluent in English, both written and spoken.
Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.
Expected Annual Base Salary Range for role: EUR 56,100 – 104,300.
The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion / EEO paragraph:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
