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Novartis zoekt een

Country Quality Manager - QP/RP

Amsterdam, Netherlands

About the Role

Location: The Netherlands, Amsterdam

If you are the person full of passion, energy, looking for innovative solutions for the patients and enjoying working in the TEAM of people sharing your inspiration and openness – this the position for YOU!

As Country Quality Manager - QP/RP you will assure that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements and you will be ensure that relevant documentation is up-to-date and archived correctly. Furthermore you will be responsible for the “state of the art” GxP know-how and future trends in the field of GxP.

Your key responsibilities:

• Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
• Review and archive batch documentation, conduct self-inspections, and monitor corrective actions
• Conduct GxP monitoring, investigate noncompliance, and manage critical quality issues
• Escalate issues per Novartis escalation policy and initiate market actions if required
• Assess quality trends and drive continuous improvement for processes and product quality
• Maintain contacts with regulatory authorities and stay updated on GxP regulations
• Support product launches in collaboration with partners and development organizations
• Ensure drug products are released in accordance with specifications and regulations
• Maintain coordinated contact with regulatory certified QP and RP

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

Essential Requirements:
• Education: Bachelor’s Degree or equivalent 4-Year University degree in a Scientific or Technology field (e.g. Chemistry, Pharmacy or other Life Science). Advanced degree preferred.
• 3+ years of relevant experience in a Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development.
Certified QP and RP
• Solid communication skills and problem solving capabilities
• Fluency in English and local language (oral and written), additional language(s) a plus.

Why Novartis :Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Novartis is focused on delivering high-value medicines that address society's most pressing disease burdens. Our aim is to create long-term value by contributing to advances in human health, delivering returns to shareholders, and benefiting society.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network (link is external)

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