Qualified Person (QP)

NL42 (FCRS = NL042) IDB Holland BV; Baarle-Nassau; On-site; EUR 56,000 - 104,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

14 weeks paid parental leave

Job summary

Novartis in the Netherlands seeks a Qualified Person responsible for batch release, ensuring product quality and compliance with applicable regulatory requirements, including cGMP, Dutch legislation, and European regulations.

This role provides quality oversight of operational activities and ensures the effective implementation, monitoring, and maintenance of a GMP‑compliant quality system, while supporting a reliable radiopharmaceutical supply.

Qualifications

• Master’s degree in a scientific discipline.
• Pharmacy background is preferred.

Responsibilities

• Review and release batch analyses in line with EU and national regulations.
• Provide quality, compliance, and technical expertise for investigations including deviations, CAPAs, changes, and complaints.
• Ensure deviations/complaints with possible impact on patient safety or supply are escalated and resolved.
• Provide quality oversight for site operations, including validation, qualification, equipment, and training.
• Draft, review, and approve GMP documents and Quality Manual updates.
• Act as SME during health authority inspections and audits.
• Support a strong quality culture through coaching, training on cGMP and on-call support.

Skills

GMP knowledge

Fluent English

Proactive ownership

Education

Master’s degree in science

Pharmacy background preferred

Job description

Salary Range

$0.00 - $0.00

Location

Baarle-Nassau, The Netherlands.

Job Description Summary

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

• 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.
• 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.

Job Description 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

The rewards of being part of our team go far beyond base pay and incentives.

• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs
• flexible and hybrid working options
• minimum of 14 weeks paid parental leave

Expected Annual Base Salary Range for role: EUR 56,100 - 104,300.

In addition, you may be eligible for a performance-based bonus depending on certain performance parameters.

Further details will be provided during the application process.

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.

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.

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?

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

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

China Cross-Border Data Transfer (CBDT) policy

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov.