Quality Assurance Manager
Depixus

Depixus

Quality Assurance Manager

  • Permanent contract 
  • Starting date:
  • 3, Impasse Reille, Paris, 75014
  • Partial remote authorized
  • Education: 3 years of college
  • Experience: > 4 years

The company

Depixus

Depixus

  • Pharmaceutical / Biotech, Health
  • From 50 to 250 employees

The job

Quality Assurance Manager

  • Permanent contract 
  • Starting date:
  • 3, Impasse Reille, Paris, 75014

  • Partial remote authorized
  • Education: 3 years of college
  • Experience: > 4 years

This position was filled!

Who are they?

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.  

Depixus
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Job description

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 

Preferred experience

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 

Depixus

Depixus

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