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Supply Chain Compliance Officer (H/F/X)

April 13th 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 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.

Mission Description

The Supply Chain Compliance Officer is responsible of the overall compliance and regulatory aspect within the Supply Chain department. This responsibility covers, but is not limited to :

  • The principal mission is to ensure the Supply Chain department compliance with Catalent Gosselies quality system requirements (Data integrity, supplier requirements, …).
  • Leading and continuous follow up for the management of deviations, CAPA, risk assessments, Change Controls, challenging and ensuring the implementation within defined timeline
  • Ensure the LLSPOC role for Supply Chain (analyze of training matrix, follow up the training plan....)
  • Manage follow up of controlled documentation for the Supply Chain department according to scheduling, including training for teams (SOP, logbooks, qualification protocols, ....), including the compliance to renewal dates.
  • Support the different project teams for critical investigations including participation to customers/Authorities/suppliers audits.
  • Provide action plan to improve our compliance
  • Technical expertise: be the Subject Matter Expert covering any questions related to training compliance, and GMP requirements for the Supply Chain Departement
  • Communication: maintain open and effective communication with all departments, with particular attention during critical investigations; be the interface between the Supply Chain department and all other departments and customer for compliance aspects related to the Supply Chain Activities; Takes part in audits (on-site and at suppliers)
  • Quality and Continuous improvement: Organizes and manages regular meetings to ensure the follow-up of all tasks linked to his/her activities - Monitor progress through KPI - Define continuous improvement plans with involved manager, and monitor progress - involved in preparation and execution of any audits/inspection

Candidate profile

  • Bachelor's degree in Science (e.g.: in biology, pharmacy, clinical chemistry, bioengineering) or relevant experience in a similar position in the sector of Biotech/Pharma/Cell therapy.
  • Good knowledge of QMS processes and GMP environment.
  • At least 4 years of experience in a similar role
  • Quality minded, rigorous, customer-oriented and continuous improvement driven
  • Aseptic production is a plus
  • Supply chain knowledge
  • Good communicator,
  • Demonstrated cross-functional team spirit.
  • Organization skills and reliable
  • Autonomous

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