QA Operations Lead & Qualified Person for Quality Excellence

Novartis; Baarle-Hertog; Vor Ort; EUR 56.000 - 104.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Leadership

Quality Assurance

Quality Control

GMP

Stakeholder Management

English Fluent

Ausbildung

Pharmaceutical Sciences degree

Qualified Person registration (NL)

Jobbeschreibung

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.