15 ans ! Notre expertise s’appuie sur plus de 15 ans d’expérience dans la production et la commercialisation d’un portefeuille de produits d’imagerie de médecine nucléaire pour un certain nombre d’indications en oncologie, neurologie, cardiologie et pour les maladies infectieuses et inflammatoires.
Your responsibilities include, but are not limited to:
•Be the primary interlocutor of the Health Authorities for subjects within the scope of its responsibility
•Ensure through adequate delegations that all pharmaceutical activities are carried out in accordance with the French Public Health Code.
•Manage and coordinate quality and promotional activities in accordance with pharmaceutical responsibility for all products marketed in France.
•Ensure compliance with requirements of the Sales Reps Certification.
•Be accountable for QA activities linked to the legal entity (i.e. notifications to HA, KQI/CAPA management, QA/cGMP escalation, monitoring, SOPs management, implementation of variations to the Marketing Authorization of an AAA product are implemented at national level, ect...)
•Participate in the policy of the French affiliate, as a member of the Leadership team; participate in the choice of strategic product orientations in conjunction with the other departments.
•Represent AAA, as needed, in various external structures such as LEEM, AFAR...
Location : Rueil Malmaison
Diversity & Inclusion / EEO
Novartis s'engage à créer un environnement de travail exceptionnel et inclusif, ainsi qu'une équipe diversifiée, représentative des patients et des communautés que nous servons.
What you’ll bring to the role
•At least 5 years of experience in a pharmaceutical quality department (QA)
•Excellent organizational skills (time management, risk management) including attention to detail and multitasking skills
•knowledge of quality system (French law and GMP)
•Basic knowledge of regulatory requirements
•Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system
•Pharmacist (Preferred qualification to Qualified Person) Registered in Section B « exploitant »
•Fluent English verbally and in writing
•A competitive salary
•An annual bonus
•A focus on your career development
•Access to our Quality of Life at work programme
•Family Mutuelle (60% supported by AAA)
•25 days of CP + JNT ( non working day) per year
•Various employee recognition programs
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Novartis has been certified as a "Top Employer" in France
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network