Qualified Person and Quality Assurance Operations Team Lead
novartis · Baarle Nassau
Job description
About the role
Join Novartis to ensure patients receive trustworthy medicines every day. As the Qualified Person and Quality Assurance Operations Team Lead you will combine quality expertise with people leadership, guiding a talented team while supporting product quality, patient safety, and operational excellence.
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.
Required profile
- 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 GMP‑regulated pharmaceutical or biotechnology environment.
- Proven experience leading, coaching, or developing individuals or teams in a regulated setting.
- Fluent English with strong communication and stakeholder‑management skills.
Required skills
- Good Manufacturing Practices (GMP)
- Quality Assurance (QA) and Quality Control (QC)
- Quality Management Systems (QMS)
- Regulatory Compliance
- Statistical Process Control (SPC)
- Supplier Quality Management
- Risk Management
What we offer
- Annual base salary €56,100 – €104,300, performance‑based bonus potential.
- Competitive benefits including insurance, retirement plans, wellbeing resources, and parental leave.
- Flexible and hybrid working options where possible.
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Published 4 uur geleden
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novartis
Baarle Nassau