Data Integrity Sr Leader
il y a 3 semaines
**Position Summary**
Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organization, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fullfill their objective of providing sustainable and affordable therapies to their patients.
To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated **Data Integrity Sr Leader**.
**The Role**
- Implement and maintain the Data Integrity program.
- At as an active member of Europe Quality Shared Services team
- Be responsible to maintain the quality systems
- Implement all Data Integrity requirements aspects in the Catalent Gosselies organization
- Ensure adequate support to implement and harmonize DI requirements through Catalent site
- Follow the Catalent Corporate Data Integrity program and deployed them on Catalent Gosselies site
- Lead the implementation on general Catalent requirement in local documentation (In place and in use)
- Define and maintain the DI training programme for the site in collaboration with Training departments
- Support the site in its development and ensure the integrity of our data throughout the processes
- Lead and participate in potential remediation programmes. Ensures the review, challenge and approval, in compliance with GMP, Deviation, CAPA, Change Control, Risk Analysis quality system documents when relevant
- Expert in the Data Integrity aspects to ensure that they comply with current regulations. Subject matter expert for the follow-up of audits and questions from customers and authorities
- Expert in GMP environment
- Good knowledge of quality tools (cGMP, Well acquainted with Change control/ deviation and market compliance management system)
- Experience of minimum 8-10 years in GMP activities with a DI aspect, preferably in a biopharmaceutical company.
- Good communication skills
- Rigorous, conscientious, flexible and honest, Quality mind, Ownership
- Willing to embrace new challenges
- Fluency in French and English and good speaking
**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
**Position Benefits**
- Full-time position (40h/week)
- An indeterminate contract
- The opportunity to take part in a growing dynamic biotech company
- A human-sized working environment with a convivial atmosphere
- Health+Group Insurance, Meal Vouchers, Eco Vouchers
- Company car
**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 faire la différence.
Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.
Initiative personnelle. Rythme dynamique. Un travail significatif.
Visitez Catalent Careers pour explorer les opportunités de carrière.
Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base d'une caractéristique protégée par la législation locale.
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