QC Manager

작업 내용

Description de l’emploi
QC Manager

Position Summary

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 modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill 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 QC Manager.

The Role

The QC Manager main role is to manage the activities in the Quality Control department.

These Activities Are Divided In These Different Fields

• A team of QC project leader
• A Biochemistry and cell culture platform
• A Flow cytometry platform
  

QC manager is concerned with sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory.

In order to fulfill these main missions, the QC manager:

People Management/communication

• Support the project leaders/supervisor when needed
• Supervises and participates in individual development of his/her N-1.
• Performs bi-weekly 1/1 to discuss N-1 issues and achievements.
• Performs annual performance review and sets up annuals SMART objectives to his/her N-1. He/she also ensures the follow-up of these objectives throughout the year.
• Ensures human well-being by a good private/professional life balance while preserving team spirit and good work atmosphere.
• Approves timesheets and holidays of his/her N-1.
• Recruits, leads and develops a part of the QC team
• Ensures right people at the right place at the right time and appropriate polyvalence/expertise ratio in a flexible environment.
• Ensures that QC personnel’s training is adequate and adapted to Catalent’s needs.
• Ensure the team works in an efficient manner.
• Maintains opened and effective communication with all other departments
• Vehicles Catalent’s values, and QC department vision and mission
• Drives the empowerment culture.
  
  

GMP Clinical/commercial Production

• Ensures appropriated resources, time and competencies in QC for Production projects
• Ensures QC planning is aligned with quality, milestones, and resources.
• Makes sure the team is focused on client expectations.
• Ensures documentation be ready on time to support RA filing (clinical or commercial)
• Ensures that all necessary testing is carried out and the associated records evaluated;
• Ensures GMP compliance and implementation of QMS, product quality and team driven by patient safety
• Preserves license to operate and ensures implementations of remarks from any audits
• Prepares and participates to audits with authorities and customers
• Develop a fit for purpose approach based on risk assessment for QMS appropriate to clinical phase project advancement (ph I, II, III) or to commercial.
• Ensures development or implementations of risk analysis tools, mitigation plans and follow up, escalade risks to upper management.
• Ensures that all necessary department documents are available and that all operators perform their duties according to the existing procedures
• Is responsible for QC GMP compliance
• Ensures that required validations are performed
• Is responsible for specification form, OOS, certificate of analysis, raw materials/consumables certificate of release (when QC testing is required), stability protocols and certificates, sampling plans, and all generic QC documents (procedures, validation protocols and reports, transfer protocols and reports, …).
• Establishes, validates and implements all quality control procedures, oversee the control of the reference and/or retention samples of materials and products when applicable, ensure the correct labelling of containers of materials and products, ensures the monitoring of the stability of the products, participates in the investigation of complaints related to the quality of the product, etc.
• Approves or rejects, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products
  
  

Prospect Evaluation & QC Prospection

• Participates to project technical evaluation in collaboration with Business
  
  

Budget

• Mentions each budget deviation to MTC business team.
• Ensures that all unexpected testing(s) related to his/her project(s) are properly communicated to business team and Project Manager.
• Identifies specific needs related to trainings of his/her team or hiring and reports to the head of Quality.
  

The Candidate

Qualifications & Experience

• At least Master level in chemistry, biochemistry, clinical chemistry, biology, etc;
• At least 10 years experience in cGMP and QC or project management
• Experience in people management is a must;
• English level: at least B2
• Computer skills: Microsoft office, ComplianceWire, Documentum, TrackWise are a plus.
  
  

Skills & Competencies

• Organization skills, multitasking;
• Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active;
• Teamwork and teaching skills;
• Good communication skills and cheerful;
  

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.
  

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

Catalent s’engage à assurer la santé et la sécurité de ses employés, ses visiteurs, des clients et patients qu’elle sert. En raison de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d’intégration afin de préserver la sécurité de chacun. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape

Catalent. Plus de produits. De meilleurs traitements. Fournis de manière fiable. ™

Visitez www.catalent.com/careers pour explorer les opportunités de carrière.

Catalent est un employeur favorisant l’égalité des chances et l’action pour l’équité . Tous les candidats qualifiés seront considérés pour un emploi sans distinction de race, de couleur, de religion, de sexe, d’origine nationale, d’incapacité, de statut de vétéran protégé, d’orientation sexuelle ou d’identité de genre. Si vous avez besoin d’une aide raisonna ble pour une partie du processus de candidature ou d’embauche en raison d’un handicap, vous pouvez soumettre votre demande en envoyant un courrier électronique confirmant votre demande d ’adaptation et en indiquant le numéro du poste, le titre et l’emplacement à l’adresse DisabilityAccommodations @ catalent. com. Cette option est réservée aux personnes nécessitant une adaptation en raison d’un handicap. Les informations reçues seront traitées par un employé américain de Catalent, puis acheminées vers un recruteur local qui fournira une assistance pour assurer la prise en compte appropriée du processus de candidature ou d’embauche.

Avis aux représentants des agences et des entreprises de recherche: Catalent Pharma Solutions (Catalent) n’accepte pas les CV non sollicités d’agences et / ou de sociétés de recherche pour cette offre d’emploi. Les curriculum vitae soumis à un employé de Catalent par une agence tierce et / ou une entreprise de recherche sans accord de recherche écrit valide et signé, deviendront la propriété exclusive de Catalent. Aucun frais ne sera payé si un candidat est embauché pour ce poste à la suite d’une recommandation non sollicitée d’une agence ou d’une entreprise de recherche. Merci.