Quality Assurance Director / Qualified Person (M/F)Offer by Large Company/SME
Bone Therapeutics S.A is a fast growing biotech company specialized in the treatment of bone diseases using cell therapy. At the forefront of science and medicine and leader in its field, the Company develops innovative cell products for the repair and regeneration of bone tissues, using its proprietary stem cell-based technology platform. With a strong portfolio of advanced clinical programs (phase II and phase III) and preclinical programs, the Company is organized as a « mini-pharma » with departments of Preclinical Research, Production, Quality Control, Quality Assurance, Regulatory, Clinic and Administrative.
To strengthen our growing organization.
Bone Therapeutics is looking for a « Quality Assurance Director / Qualified Person » (M/F). You will play an essential role in all manufacturing operations from a quality perspective. This position oversees Manufacturing Quality in accordance with GMP, national and international regulations, company policies and procedures. You will be working with Manufacturing and Quality Control. Position duties include, but are not limited to oversight of production and QC activities, batch release, review and approval of procedures... You will report directly to the Chief Executive Officer.
You will be in charge:
- Ensure review and review batch record and raw materials report for release.
- Ensuring risks are identified and appropriately managed.
- Lead teams and associated activities to ensure deviations are tracked and resolved in a timely manner, applying appropriate CAPA and effectiveness checks. Ensure systemic or repeated deviations are elevated to upper Quality Management.
- Ensure GMP documents are reviewed in timely manner by appropriately training staff members.
- Check the implementation of appropriate controls and systems (on products, facility systems, and equipment).
- Ensure validation of premises, equipment, manufacturing and analytic processes.
- Adhere to all applicable procedures, GMP, company policies and any other quality or regulatory requirements.
- Answer to quality claims and ensure the implementation of immediate actions and preventive measures.
- Ensure manufacturing and quality control staffs are appropriately trained to support operations.
- Ensure continuous quality improvement, and organize internal audits and suppliers / subcontractors audits, oversee their achievement and track action plans.
- Follow and apply new specific regulations regarding products, labeling and process.
- Qualified Person (registered to FAMHP)
- At least 3 to 5 years of experience in pharmaceutical industry
- Relevant experience in GMP production
- Accurate and rigorous, reliable and fast independent
- Project management skills and ability to recognize problems and react quickly
- High level of planning and organizational skills and fine attention to detail
- Flexible team player with the ability to work independently in a changing environment
- Fluent in French and English; Dutch is an asset
- Immediate start
- Long-term contract (CDI)
- Position based in Anderlecht (Brussels) and Gosselies (South of Brussels)
Nr of positions available : 1
Experienced researcher or 4-10 yrs (Post-Doc)
Established Researcher (R3)
Comment/web site for additional job details
To better plan and organise their stay in a foreign European country, researchers and their families can also benefit of the free and personalised assistance offered by the EURAXESS Services Centres, a network of more than 200 centres located in 40 different European countries.
BONE THERAPEUTICS S.A.
Rue Adrienne Bolland 8
Publish your job vacancies & fellowship programmes or Post your CV
ERC National Contact Points