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QA CUSTOMER & COMPLIANCE LEAD (H/F/X) (h/f)

Ref 1382203

Geactualiseerd op 23 februari 2021 via 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 motivated QA Customers & Compliance Lead.
 
The Role
The QA Customers & Compliance Lead reports to the QA Customer & Compliance Manager and is responsible to:
In relation with specific QA customer & compliance activities:
Be a Subject Matter Expert covering QA questions related to project initiation QA activities, by customers or internal teams.Be the interface between the QA department and all other Catalent departments and customer for QA aspects related to projects he/she is leading.Warn/ report periodically the QA Customer & Compliance manager in case of issue.Ensure for the project he/she is leading the QA documentation review against regulatory files, current regulations and customer requests.Ensure QA Readiness of the project he/she is leading at every steps.¿Follow customer related deviations, OOS, change control, risk assessments, CAPA, complaint.Ensure Batch Disposition¿ of the project in collaboration with the QA Customer & Compliance Manager.To ensure to have the appropriate training before performing an activity and updates QA training related to his/her activity.Ensure customers expectation are fulfilled.Communicate and to interact effectively with the colleagues of QA department for QA aspects related to projects he/she is leading (e.g. for initial manufacturers/suppliers/ subcontractors' approval, for equipment management lent by customers, for document review, etc.).Participate to Quality Agreement establishment with customers¿.The QA Customer & Compliance Lead is the back-up of the QA Customer & Compliance Manager for project launch aspects.
 
In relation with CTLT values and performance:
Vehicle Catalent values, QA department vision and mission.Ensure a Patient First Culture.Implement pertinent tools of operational excellence Lean culture.Implement and follow-up Key Performance Indicators. He/she proposes and takes appropriate actions.Feed and support initiatives in Environment Health and Safety protecting life and well being
 
Transversal and/or regulatory activities:
Maintain an open and effective communication with all other departments.Take part to audits when necessary.Follow competent authorities and customers audit¿s and the related CAPA plan.Contact regulatory agency.Participate and ensure regulatory monitoring.Perform self-inspections
 
The Candidate
Qualifications & Skills
At least Master degree or higher in Sciences and relevant experience in cell and gene therapy.Experience of minimum 5 years in quality assurance is required.Efficient communicator and willing to bring new challenges.Demonstrated leadership and cross functional team spirit.Rigorous, conscientious, organized, versatile, open-minded & quality-minded.Ability to multi-task and demonstrate diplomatic and leadership skills.Customer oriented.Demonstrates initiative and ability to meet deadlines.Ability to effectively present information and respond to questions from 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.Knowledge of existing and emerging social media technologies and channels a plus.
 
Catalent's standard leadership competencies that are used to interview and for Perf

Profiel

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Talenkennis

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

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