Quality Assurance Manager

Quality Assurance Manager/ Regulatory Representative

Depixus® is a fast-growing venture-funded life science tools company, with over 50 staff based in both Paris and Cambridge, UK, bringing to market its award-winning MAGNA™ platform.  MAGNA™ will take researchers beyond the limitations of current day sequencing to reveal new insights into the dynamic genome, enabling important advances in clinical research and drug development. 

This role presents a genuinely exciting and unique opportunity to play a pivotal role in a talented and diverse multinational team at a key stage in the company’s evolution. 

 

Description 

As we are approaching the launch of our instrument system as well as the associated sample preparation kits and reagents, we are currently looking for a QA/regulatory representative to implement the quality system of the company.  

 

As a Quality assurance and regulatory manager at Depixus, you will: 

  • Design & implement the quality policy
  • Liaise with department representatives
  • Implement and support quality management system (QMS/GED) 
  • Train team members to the use of the system and encourage good practices
  • Redact and keep updated high quality documentation in constant connection with the appropriate teams and across teams
  • Implement and follow up deviation, CAPA and change control
  • Ensure regulatory requirements are followed
  • Keep up to date to the latest regulatory requirements or guidelines relevant to the field
  • Participate in the risk analysis as well as the implementation of actions to mitigate these risks
  • Establish internal audits for product fabrication
  • Review and approve the future products release (RUO kits)
  • Review and approve documentations intended to customers

 

This role would suit you if you:   

  • At least 5 years of relevant experience in Quality Management
  • Demonstrate good organisational skills 
  • Have sharp attention to details
  • Have knowledge of using a QMS 
  • Have knowledge and experience in the regulatory landscape of RUO kits (Experience with regulation around CE–IVD kit production will be seen as favourable), experience in reagents would be appreciated
  • Have good interpersonal and communication skills allowing to support the implementation of the quality management system across various department and sites
  • Integrity, critical and analytical thinking, cooperation, team spirit and proactivity are essential
  • Able to communicate in English and French, both in writing and orally
  • Enjoy working in a dynamic start-up environment

 

Recruitment process 

  • Visio interview with the HR team
  • Technical test
  • Technical interview
  • Final interview on site

 

Equal Opportunity at Depixus 

 Depixus an equal opportunity employer and values diversity. We are committed to providing an inclusive environment for all employees. All employment is decided based on qualifications, merit and business need. 

 

You can read more about Depixus and MAGNA on our website (www.depixus.com)

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