Junior GLP /GcLP QA Officer

14/10/21

Location

Technologiepark-Zwijnaarde 21, Gent, Belgium

Function type

Quality Assurance

Vacancy

About the Opportunity

Join Ablynx, a Sanofi company as a Junior GLP/ GcLP QA Officer responsible for supporting the implementation and maintenance of the general integrated quality management system in compliance with the current GLP and GcLP requirements and Quality Management processes of Sanofi.

This full-time permanent position will be based in Ghent, Belgium.

About Ablynx

Ablynx, a Sanofi company, is engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs.

Nanobodies have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.

About growing with us

In this role, you will…

  • Responsible to maintain the quality management system in accordance with internal and external (inter)national standards and guidelines

  • Provide support, in collaboration with the operational staff, for the set-up and implementation of procedures to assure that development activities are conducted in accordance with internal and external (inter)national standards and guidelines. Perform or supervise the QA reviews of the GLP documents

  • Take ownership of the operational quality support of projects, incorporating the risk-based approach, assist and guide the GLP-Pharma department in quality-related topics

  • Responsible for the planning and timely execution of Quality Management process improvements. Responsible to perform QA inspections on study documentation and critical phases of studies

  • Organize and follow-up the required GLP and GcLP trainings

  • Perform self-inspections 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. Establish written agreements with third parties defining the quality requirements. Guarantee the follow-up of the corrective/ preventive actions and continuous evaluation of third parties

  • Provide support in preparation of and act as spokesperson during regulatory and monitoring authority inspections

About you

Qualifications/ Education & work experience

  • Master or PhD in a relevant field of life science with preferably 5 years of experience in a GLP regulated environment

  • Vision on QM and combining analytical skills with process thinking

  • Experience with GLP or GcLP guidelines or experience with international standards related to a laboratory setting

  • Experience in and affinity with GLP regulations concerning Computerized Systems is an asset

  • Team player, enthusiastic, independent and self-motivated

  • Excellent communication and writing skills are required

  • Sense for initiative, quality, accuracy and detail

  • Oral and written fluency in English, Dutch is an asset

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 attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management)

  • 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.

If you feel you have the required experience please apply, alternatively contact sandra.rombi@sanofi.com directly for more details.

https://www.sanofi.com/en/careers/

Own your future. Make your move!

We are proud to have been awarded Global Top Employer 2021!

Job application