3! The 3 essential elements that shape our culture: Inspired. Curious. Unbossed. Our mission is to discover new ways to improve and extend peoples’ lives.
The Development Quality Manager is responsible for the quality oversight to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines to assure the execution of high quality research and activities within the Netherlands. Activities in scope include but may not be limited to assuring adequate systems are in place for the protection of patient safety, rights and well-being, data integrity, oversight of local Investigational Medicinal Product (IMP) release, and quality oversight of Clinical and Pharmacovigilance activities as needed in both pre- and post- market settings.
Your responsibilities include, but not limited to:
Quality oversight of Clinical and PV activities;
Ensuring the quality and compliance of Global Drug Development (GDD), Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs;
Ensures implementation of the Novartis Quality Manual and Quality Management System;
Collaboration with local colleagues (Clinical Operations, Patient Safety and Regulatory Affairs), Medical Affairs and Country QA to ensure compliance to both Novartis requirements and relevant HA regulations and guidance;
Lead the activities relating to Clinical and PV audits and inspections;
Lead the local Quality Review Board;
Risk Identification and Management.
What you’ll bring to the role:
Completed Bachelor’s degree in Life Sciences or related fields;
Proficiency in English in speaking and writing;
Minimum of 3 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, registration, clinical development;
Excellent communication skills;
Project management skills.
A curious, unbossed and inspiring international work environment;
Being a part of the dynamic, diverse and flexible (international team), responsible for many of tomorrow’s innovations;
Plenty of chances to work on your personal development;
Excellent working conditions.
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!
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
Do you have any questions about this vacancy? Please feel free to contract the Novartis Recruitment team at email@example.com