About the opportunity
Join Ablynx as GMP QA Officer / Management Specialist to manage the daily quality activities of the Ablynx GMP QC laboratory.
In this role, your main responsibilities are to set-up, implement and follow up the implementation and maintenance of the Quality Management System in compliance with the GMP requirements.
You will be working in an organisation where a Quality mindset runs through all aspects of operations.
Ablynx, a Sanofi company, is a biopharmaceutical company dedicated to creating new antibody-based medicines called Nanobodies® which are making a real difference to society.
Ablynx currently has over 400 people working on the development of Nanobodies for the treatment of a wide range of diseases, including inflammation, immuno-oncology and rare diseases.
About growing with us
In this role you will
Set-up and maintain the quality management system of the GMP QC laboratory in accordance with internal and external (inter)national standards and guidelines
Support the definition, set-up and implementation, in collaboration with the operational staff, of procedures to assure development activities are conducted in accordance with internal and external (inter)national standards and guidelines
Operational quality support of projects, incorporating the risk-based approach
Plan and timely execution of Quality Management process improvements and timely implementation of new or updated procedures
Perform QA reviews on project documentation
Organize and follow-up the required trainings
Perform internal audits to verify the compliance of the Ablynx Quality Management System. Guarantee the follow-up of the corrective and preventive actions
Audit third parties to assure that processes used and / or data generated by these third parties meet all quality standards.
Establish written agreement with third parties defining the quality requirements. Guarantee the follow-up of the corrective action / preventive actions and continuous evaluation of third parties
Provide support in preparation of and act as spokesperson during regulatory inspections
Qualifications / Education & work experience
Master or PhD in a relevant field of life sciences
3-5 years of experience in the pharmaceutical and / or Biotechnology industry
Knowledge of applicable GMP regulated environment
Experience with document control systems
Knowledge of health authority’s guidelines and regulations regarding GMP
Good knowledge of MS Office
Very good knowledge of English (written and spoken)
Excellent negotiating and influencing skills
Good organization skills to be able to follow multiple studies and audits
Inspire your Journey, what Sanofi can offer you :
An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
An individual and well-structured introduction and training when you onboard
You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully
As a globally successful and constantly growing company, Sanofi provides international career paths as well
This is our Sanofi, Discover yours.
We are proud to have been awarded Global Top Employer 2021.
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.