Job Title: Director Quality, Head Pharmacist
Location: Beinheim, France
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Director Quality, Head Pharmacist is responsible for setting the strategic direction, properly staffing and maintaining the Quality Management Systems (QMS) to assure the site is always complaint. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality at the site is the most responsible person for batch disposition. The Director of Quality is responsible to provide project guidance and support and work with customers to resolve quality concerns as appropriate. le
As Head pharmacist you will be responsible to ensure legal pharmaceutical responsibility for the site.
The Role
Direct a team of Quality professionals. Provide development and disciplinary actions as needed to assure the department remains engaged and motivated.
Manage and drive relations with French and international authorities & ensure compliance with the CSP (French Health Code), GMP (Good Manufacturing Practices)
Responsible for the management of manufacturing licenses, GMP certificates, SMF (Site Masterfile) and import and export licenses
Organize and monitor all the company's pharmaceutical operations, including research and development, manufacturing, control, release, pharmacovigilance, batch tracking and withdrawal, distribution, import and export of medicines and corresponding storage operations;
As a Qualified Person/QP, ensure responsibility for the compliance of productions upon departure from the site or even the release of lots according to agreements with customers
Report to other company or organization leaders any obstacles or limitations to the exercise of these responsibilities.
Informing the General Manager of the competent authority in case of disagreement on the application of the rules adopted in the interest of public health is opposed to a management, administration, management or control body
Participates in the deliberations of the governing, administrative, management or supervisory bodies, or those of any other body with an executive office, the company or the organization, when these deliberations relate to the performance of the tasks under its responsibility or may affect them.
Other duties as assigned.
The Candidate
License to practice as a head pharmacist/Qualifies Person with at least 3-4 years in a similar position working for a pharmaceutical company’s quality function.
Ability to bring projects to a timely completion using Catalent systems
Good working knowledge of the subject area
Knowledge of cGMP, GLP, ICH, and EP, USP, BP regulations or guidelines
Expert knowledge as head pharmacist and qualified person according to French Health Code art. R.5124-36.
Languages: French (main preference native speaker) & English, business fluent
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
Catalent offer 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.
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.
Si, en raison d’un handicap, vous avez besoin d'un aménagement raisonnable pour une partie ou plus du processus de candidature ou d'embauche, vous pouvez soumettre votre demande en envoyant un courriel et en confirmant votre demande d'aménagement et en incluant le numéro de poste, le titre et le lieu à DisabilityAccommodations@catalent.com. Cette option est réservée aux personnes ayant besoin d'un aménagement en raison d'un handicap. Les informations reçues seront traitées par un employé de Catalent aux États-Unis, puis acheminées vers un recruteur local qui fournira une assistance pour assurer une prise en compte appropriée dans le processus de candidature ou d'embauche.
Avis aux représentants des agences et des cabinets de recherche : Catalent Pharma Solutions (Catalent) n'accepte pas les curriculum vitae non sollicités d'agences et/ou de cabinets de recherche pour cette offre d'emploi. Les curriculum vitae soumis à tout employé de Catalent par une agence tierce et/ou une société de recherche sans un accord de recherche écrit et signé valide, deviendront la propriété exclusive de Catalent. Aucuns frais ne seront payés si un candidat est embauché pour ce poste à la suite d'une recommandation non sollicitée d'une agence ou d'un cabinet de recherche. Merci.