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Réf 1382209

Actualisé le 23 février 2021 par MASTHERCELL

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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 lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated QA Third Party Manager.
The Role
The QA Third Party Manager reports to the QA Director and is responsible with his team to:
Approve and monitor GxP providers, suppliers, subcontractors and HBM providers by co-ordinate, manage and realize audits and establish quality contractsManage the Approver Provider, Supplier and Subcontractor list.Manage the QA oversight of outsource GxP materials & services and Human Body Material activities.Back up/delegations of specific tasks falling within the competence of the HBM responsible person. (i.e: donor selection and acceptance, acceptance of the Human Body Material at the entrance of the Human Body Material establishment, temporary and final release of the Human Body Material, allocation and distribution of the Human Body Material).Review the deviations, CAPA, Risk Analysis, OOS, Change Control.Manage third-party Quality Incident.Manage the complaints to the third-parties.Manage the third-parties notifications.Participate to the risk classification of the materials Participate of the elaboration of the Annual Quality Review and Annual Product Review.Ensure to give the necessary assistance in case of complaints or product recall.
The QA Third Party Manager is responsible to:
Ensure a Patient First Culture.Lead the QA Third Party department in order to guarantee the proper functioning of his departmentAct as the Quality Assurance interface between providers, suppliers, subcontractors and Responsible Person of the Intermediate Structure and Biobank.Maintain the Quality Assurance documents links to his department, the Intermediate Structure and Biobank.Establishing Key Performance Indicators and trends regarding the team's activities.Report potential and confirmed budget deviation.Ensure that the required initial and continuing training of his team is carried out and adapted according the needs.Supervise the activities of his team to achieve their goal.Recruits and put in place individual development plan and resolve team conflicts.Drive the empowerment culture.Maintain opened and effective communication with all other department.Ensure the completion and analysis off the time sheets related to his team.Update QA training Matrix related to his activity.With the collaboration of the training department, gives QA site training related to his activity.Perform self-inspections.Develop the mindset of continuous improvement culture.Implement pertinent tools of operational excellence Lean culture.Feed and support initiatives in Environment Health and Safety protecting life and well being.
The Candidate
Qualifications & Skills
At least Master's degree or higher and relevant experience in cell and gene therapy.Strong organisation skill.Experience in quality assurance.Ability to multi-task and demonstrate diplomatic and leadership skills.Demonstrates initiative and ability to meet deadlines.Excellent verbal and written communication skills to convey and receive ideas and instructions to/from others within the organization.Ability to effectively present information and respond to questions from peers, management and customers.Fluency in French: good speaking, reading and writing skills.Good reading comprehension and writing skills in English.Computer skills: Microsoft office, ETQ, ComplianceWire, TrackWise are a plus



Connaissances linguistiques

Français : Bon
Anglais : Moyen
  • Gestion d'entreprises, de services et de projet / Gestion de services

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