- Pharmaceutical / Biotech, Health
- From 50 to 250 employees
Quality Assurance Manager
- Permanent contract
- Starting date:
- 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.
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
· Visio interview with the HR team
· Technical test
· Technical interview
· Final interview on site
Interested in this offer?
- Share on LinkedIn
- Share on Facebook
- Share on Twitter