Director, Quality
SOPHiA GENETICS, France

Have you owned Quality Assurance for IVD products on an international field? Do you want to drive our quality strategy as we pioneer into newly discovered fields and combine complex, multi-modal data into our fully integrated SaaS platform.

Bring your knowledge and passion to SOPHiA GENETICS as our new Director, Quality.

In line with requirements, this individual must be located in France. Ideally you will be located within proximity to our Bidart office, but suitably qualified hybrid/remote candidates are encouraged.

As an international organisation, our business language is English. CVs must be submitted in English for successful review.

Your mission:

Reporting to our Chief Legal Office and sitting as our EU Authorised Reprensentative, you will lead our QA Team and ultimately be responsible for our global (IVD) medical device products.

What you'll achieve:

• Own the global eQISMS, ensuring compliance with requirements, effective and initiaiate continuous improvements.
• Develop and executive quality policies to achieve corporate strategic goals.
• As Authorised Representative PRRC, be the primary contact in audit for notified bodies.
• Seve as an escalation point for all quality issues including CAPA / Complaint / Recall / NC's and Change control.
• Be directly responsible for our QA Team

Requirements

What you'll bring:

• You'll likely have 7-10 years experience within Quality Assurance, with 3+ years exposure to directly leading teams.
• You must have previous experience within IVDs as an RA or QA professional to sit as the PRRC for the EU-AR. Experience across Pharmaceuticals without IVD experience is less relevant and unsuitable.
• Additional exposure to Software as a Medical Device highly valuable.
• Strong working knowledge of relevant regulations including ISO 13485 / 14971, GxP and similar.
• BSc, MSc or PhD in a scientific discipline.
• Full written and oral fluency in English (CVs must be submitted in English)

Benefits

You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we drive exponential growth.

The Process:

Apply now with your CV and any supporting information. For further information, contact our Senior Talent Acquisition Lead for Critical Hiring.

Suitably qualified candidates will be invited through an interview and screening process where you will speak with members of our Talent Acquisition Team, the hiring leader alongside key colleagues and stakeholder from across the business.

Starting date: ASAP as agreed

Location: Office (Bidart) or Hybrid/Remote as agreed (FR)

Contract type: Permanent, Full-time

Job Rewards and Benefits