Qualified Person (QP)

Novartis AG; Baarle-Nassau; On-site; EUR 56,000 - 104,000; Full time

Benefits offered by this job

Hybrid working options

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

14 weeks parental leave

Job summary

Novartis AG in Baarle-Nassau, The Netherlands, seeks a Qualified Person to oversee batch release, ensure product quality, and maintain GMP-compliant systems. This onsite, full-time role requires deep QA expertise and a proactive, hands-on approach to regulatory compliance.

You will review batch analyses, support supply chain reliability, lead investigations into deviations and CAPAs, and act as SME during inspections. Fluent English and a Master’s degree are required, with 3+ years in pharma QA.

Qualifications

• Master's degree in a scientific discipline; Pharmacy preferred.
• 3+ years of experience in a similar QA role within pharma/biotech.
• Strong knowledge of GMP and applicable pharmaceutical regulations.
• Hands-on and proactive working style with ownership.
• Agile mindset with clear priorities and collaborative approach.
• Fluent in English, written and spoken.

Responsibilities

• Release batch analyses on site to support reliable product supply.
• Provide quality oversight for site operations and quality management activities.
• Write, review, and approve GMP documentation and procedures.
• Act as SME during health authority inspections, audits, and internal reviews.
• Investigate deviations, CAPAs, changes, and product quality complaints.
• Coach and train staff on cGMP requirements and best practices.
• Deputize for the Quality Operations Manager when required.

Job description

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 is based in Baarle-Nassau, The Netherlands.

• Onsite
• Job Type: Full time
• Employment Type: Regular
• Shift Work: No

Summary

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-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.