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Deputy Responsible Person - Intermediate Structure (H/F/X)

June 23rd 2021

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.

Mission Description

The Deputy Responsible Person Intermediate Structure main role is to ensure the overall quality, safety and traceability of tissues and cells as starting material for Advanced Therapy Medicinal Products (ATMPs) in the Intermediate Structure.

In order to fulfill his/her role, he  is focused on all the operation related to the Accredited Tissue Establishment including but not limited to:

  • Establish and maintain in compliance with the current legislation the processes of importation, receiving, storage, distribution, traceability, release and destruction of the Human Body Material;
  • Ensure the procurement of the Human Body Material through authorized establishments;
  • Ensure the traceability of the Human Body Material received till the used in the GMP activities;
  • Collect the appropriate data to give the ability of the Responsible Person to release the Human Body Material;
  • Archiving of the files link to the Human Body Material
  • Release the Human Body Material when the Responsible Person is not available;
  • Detect, analyze, report the deviation related to the Accredited Tissue Establishment of Human Body Material processes;
  • Collect and notify adverse event to the Responsible Person;
  • The training of the Catalent persons involved in the processes of the Accredited Tissue Establishment of Human Body Material;
  • The establishment and maintain of Key Performance Indicators link to the processes of the Accredited Tissue Establishment of Human Body Material.
  • In case of short absence of the Deputy Responsible Person - BioBank, he maintains the activity of the BioBank in compliance with the current legislation.

Candidate profile

Qualifications & Skills

  • Medical Doctor with experience in Tissue Establishment is an asset
  • 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.
  • Knowledge of existing and emerging social media technologies and channels a plus
  • 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

Offer

  • 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

Contact Details

To apply for this job, please send your application on the following link : Catalent