Qualified Person and Quality Assurance Operations Team Lead

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

Job summary

Novartis is seeking a Qualified Person and QA Operations Team Lead based in Baarle-Nassau, the Netherlands. The role combines quality leadership with hands-on release decisions to ensure medicines meet safety and quality standards.

You will lead a team of QA specialists, drive continuous improvement, and partner across Manufacturing, QC and Technical Operations to resolve challenges in a GMP environment.

Qualifications

• Registration as a Qualified Person in the Netherlands, or eligible via a Pharmaceutical Sciences degree.
• At least five years of GMP-regulated pharmaceutical/biotech experience.
• Experience in quality assurance, quality control, manufacturing, or GMP function.
• Proven experience leading, coaching or developing teams in a regulated environment.
• Strong knowledge of GMP regulations, quality systems, risk management and product disposition.
• Fluent English with strong cross-functional communication.

Responsibilities

• Act as the Qualified Person, ensuring compliant certification and release of medicinal products.
• Lead a team of Quality Assurance Specialists, fostering collaboration and continuous improvement.
• Oversee quality operations and GMP compliance.
• Make risk-based quality decisions to protect product quality and patient safety.
• Partner with Manufacturing, Quality Control and Technical Operations to resolve quality challenges.
• Drive operational excellence initiatives to improve efficiency, quality performance and inspection readiness.
• Coach team members and support development.
• Strengthen quality systems through proactive risk management and continuous improvement.

Skills

Leadership

Quality Assurance

Quality Control

GMP

Stakeholder Management

English Fluent

Education

Pharmaceutical Sciences degree

Qualified Person registration (NL)

Job description

Summary

Location: Baarle-Nassau, the Netherlands

Location: Baarle-Nassau, the Netherlands

Relocation Support: This role is based in Baarle-Nassau, the Netherlands. Novartis is unable to offer relocation support: please only apply if accessible.

Join Novartis and help ensure that patients receive medicines they can trust every day. As the Qualified Person and Quality Assurance Operations Team Lead, you will combine your quality expertise with people leadership, guiding a talented team while making decisions that directly support product quality, patient safety, and operational excellence.

In this highly visible role, you will build strong partnerships across the organization, foster a collaborative and growth-oriented team culture, and help create an environment where continuous improvement and learning thrive. If you are passionate about developing people, advancing quality excellence, and making a meaningful impact, we would love to hear from you.

About The Role

Key Responsibilities

• Act as the Qualified Person, ensuring compliant certification and release of medicinal products.
• Lead a team of Quality Assurance Specialists, fostering collaboration, accountability, and continuous improvement.
• Oversee quality operations and maintain compliance with Good Manufacturing Practice requirements.
• Make risk-based quality decisions that protect product quality, patient safety, and regulatory compliance.
• Partner with Manufacturing, Quality Control, and Technical Operations teams to resolve quality challenges.
• Drive operational excellence initiatives that improve efficiency, quality performance, and inspection readiness.
• Coach team members through constructive feedback, development opportunities, and supportive leadership.
• Strengthen quality systems and processes through proactive risk management and continuous improvement.

Essential Requirements

• Registration as a Qualified Person in the Netherlands, or a Pharmaceutical Sciences degree with eligibility for registration.
• At least five years of experience in a Good Manufacturing Practice regulated pharmaceutical or biotechnology environment.
• Relevant experience in quality assurance, quality control, manufacturing, or another Good Manufacturing Practice function.
• Proven experience leading, coaching, or developing individuals or teams in a regulated environment.
• Strong knowledge of Good Manufacturing Practice regulations, quality systems, risk management, and product disposition decisions.
• Fluent English and strong communication and stakeholder management skills across multiple functions.

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: €56,100 to €104,300.

The base 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.

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 minimum 14 weeks paid parental leave.

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

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:

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)