QA System

**The Role**

Ensure the maintenance and the improvement of the Quality Management system and the compliance with applicable US/EU regulations, guidances and Catalent policies/procedures.

Bring the appropriate support to Quality Assurance manager regarding the design, effective implementation, monitoring and maintenance of the quality management system of the ATMP manufacturing (Cell Therapy and Plasmid), importation, distribution entity
- Quality Management System activities :_
- Update, in compliance with the current regulation the QA quality system documents
- With the collaboration of concerned department, establish annually the Annual Quality Review (AQR) and Quality Management Review (QMR)
- Support the QA System Manager in the production of KPIs and appropriate reporting for Corporate meetings when relevant
- Act as Subject Matter expert covering QA questions, related to QA system, by customers, internal teams or during external audit.
- Review, challenge and approve, in compliance with GMP, Deviation, CAPA, Complains, Audits, Change Control, Risk Analysis quality system documents.
- Identify and determine quality improvement and recommend appropriate solutions.
- Update and take adapted action to maintain of deviation, CAPA, change control, risk analysis with KPI.
- Review data analyse results and recommend changes based upon findings and perform follow up to verify effectiveness.
- Third Party Activities :_
- Manage the QA oversight of the GxP suppliers.
- Maintain the Gosselies’s approved suppliers list up to date
- Provide supporting data to the Global Supplier Quality Management Team for the performance of supplier audits
- Assess supplier notifications of change with internal stakeholders and follow-up until closure
- Give support to write supplier complaints with internal stakeholders, follow-up with the supplier, assess the response provided by the supplier and close the complaints.
- Write, coordinate, issue and maintain supplier quality agreements
- Lead the performance of supplier risk assessments
- Prepare and analyze metrics related to supplier quality management topics: IR score card, Management Review, Annual Quality Review,
- Be the contact point for Gosselies site in case of questions or training related to the supplier quality management system.
- Present the supplier quality management system during customer audits, regulatory agency inspections, internal audits,
- Closely work with the Global Supplier Quality Management Team in order to implement corporate policies / quality standards in Gosselies’ quality management system.
- Initiate, review or approve quality records (change controls, deviations, ) linked to the supplier quality management system
- Plan, coordinate (scheduling, and reporting) and perform audits of the plant systems and procedures.
- Ensure to have Risk Management quality system documents up-to-date.
- Identify and develop Continuous Improvement projects
- Implement pertinent tools of operational excellence “Lean culture”.
- Implements and follows-up Key Performance Indicators.
- Degree in bioengineering, (bio)chemical engineering, biotechnology or other science related field
- ** Min 4** years of experience in Quality
- Experience with QMS system and 3rd party relation is preferred
- Experience in a CDMO organization is a plus
- Experience in CI is a plus
- Fluent in English, good command of French preferred
- Able to lead and guide
- Good communication and collaboration skills
- Hands on approach needed
- ** Strong decision making skills** based on solid data and risk assessments
- Able to work in a fast-paced and dynamic environment

**Position Benefits**
- Full-time position (40h/week)
- An indeterminate contract
- The opportunity to take part in a growing dynamic biotech company in a human-sized working environment with a convivial atmosphere
- Health & Group Insurance
- Meal vouchers, Eco-vouchers

**Catalent’s standard leadership competencies that are used to interview and for Performance & Development**:

- Delivers Results
- Leads with Integrity and Respect
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops

**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour fa