About the Opportunity
Ablynx, a Sanofi Company, is inviting applications for the role of Quality Officer.
As Quality Officer, your main responsibilities are to set-up, implement and follow up the implementation and maintenance of the Quality Management System in compliance with requirements of their respective GxP area (GMP, GLP) and/or R&D area.
About Sanofi Genzyme
Sanofi Genzyme is the specialty care global business unit of Sanofi, focused on rare diseases, multiple sclerosis, oncology, immunology and rare blood disorders. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.
Our ambition is to be the industry leader in specialty care. We currently provide more than 20 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.
· Responsible to set-up and maintain the quality management system in accordance with internal and external (inter)national standards and guidelines.
· Responsible to support the definition, set-up and implementation, in collaboration with the operational staff, of procedures to assure development and commercialization activities are conducted in accordance with internal and external (inter)national standards and guidelines.
· Responsible to perform a QA review on project documentation.
· Responsible to organise and follow-up the required trainings.
· Responsible to perform internal audits to verify the compliance of the Ablynx Quality Management System. Guarantee the follow-up of the corrective and preventive actions.
· Responsible for auditing third parties to assure that processes used and/or data generated by these third parties meet all quality standards.
· Responsible to provide support in preparation of and act as spokesperson during regulatory inspections.
To excel in this role you will need to have:
· Master or PHD level education in a relevant field of life science with knowledge of applicable GxP regulated environments.
· A first experience in GxP within a Pharmaceutical or Biotechnology industry.
· Experience with document control systems.
· Knowledge of health authority’s guidelines and regulations regarding GxP / R&D.
· Very good knowledge of English.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we live by are teamwork, courage, respect and integrity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.