Quality Assurance Systems Specialist – Exothera

Exothera is a contract development and manufacturing organization (CDMO) dedicated to virus and viral vector production.

As a Univercells company, Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated processdevelopment/optimization to rapidly reach GMP clinical and commercial production of virus and viral vectors. 

At Exothera and Univercells, our mission is to make health equally accessible to all. 


The QA Systems Specialist is the Point of contact for eQMS inside the QA team, the point of contact for QMS for the Exothera team and the owner of systems: risk assessment, customer audits and inspections.


  • Single point of contact for all topics regarding QMS (Deviation, change control, CAPA, audits, risk assessment, training, documentation…)
  • Interaction with QA Univercells for change/improvement in QMS system
  • Risk assessment owner: collect the quality risks, document with the owner, follow up of risk with associated mitigation
  • Quality council owner: preparation, presentation to leadership team, follow up of actions
  • Change control owner: lead the change control committee board, follow up of Change control (including administrative closure)
  • Audits/inspections leader: lead the preparation, coordination, manage the audit response and CAPA follow up. 
  • SPOC for eQMS inside the Exothera QA team
  • Support questions from operations teams related to eQMS system (Mastercontrol)
  • SPOC and point of contact for audit related to quality system topics: deviations, change control…
  • Be part of the implementation of eQMS modules (testing with QA Univercells, Exothera procedure drafting, testing and training for Exothera team)
  • Respect EHS rules and instructions
  • Collaborate with employer, EHS department and hierarchical line in: 
  • performing risk analysis
  • accident/incident investigations
  • proposal of preventive/corrective measures regarding to avoid risks.
  • Attend the EHS training sessions organized
  • Flag up risks and unsafe situations


  • M. Sc. or equivalent in scientific discipline
  • Minimum 3 years’ combined experience in biotechnology/cell and gene therapy environment, covering QA and/or manufacturing
  • Good GMP/GDP knowledge
  • Ability to work in fast-paced and agile environments 
  • Fluent English (both written and spoken), French is an asset
  • Demonstrate day-to-day application of the company’s values
  • Excellent influential skills
  • Strong in communication and team player