QA Operations Senior Manager
il y a 3 jours
Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.
To manage the QA Operations team we are hiring a **QA Operations Senior Manager**, you will be reporting to the QA Director
The QA Ops Team is responsible for the direct quality oversight of GMP manufacturing activities, including material management in the production of clinical and commercial cell therapies
**The Role**
- Prepare status reports to monitor the deliverables of the team and corrects as needed
- Drive high team performance
- Function as a Senior Quality member of Deviation, CAPA and Change Control Boards
- Actively work with the team to adequately resolve problems
- Actively work the team to evaluate risk assessments to support adequate decision making
- Escalate problems and propose solutions in a timely manner
- Ensure that Quality approvals of associated documentation to batch start and batch disposition are done in time
- Liaise with customers and Senior Leadership as needed
- Act as Deputy of the Director QA when requested
- Degree in bioengineering, (bio)chemical engineering, biotechnology or other science related field
- ** 8-12** years of experience in the biopharmaceutical industry. Experience in **both Manufacturing and QA roles highly preferred**
- Experience in the ATMP industry is a plus
- Experience in a CDMO organization is a plus
- Experience in Operational Excellence is a plus
- Experience with Batch Record Review, Deviation/CAPA and Change Control
- Experience in batch disposition is a plus
- Experience managing a team. Able to serve as a mentor
- Fluent in English, good command of French preferre
- Good communication and collaboration skills
- A solution-oriented approach to complex situations
- Strong critical thinking skills
- 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
- Company car
**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 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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