Do you want to navigate the regulatory life cycle of SOPHiA GENETICS products, as we pioneer into newly discovered fields and combine complex, multi-modal data into our fully integrated SaaS platform? Are you innovative and passionate to be a proactive influencer on regulatory authorities?
Bring your knowledge amp; passion for healthcare toSOPHiA GENETICSas our new Quality Specialist for Bidart in France.
Why us:
We believe there is a smarter, more data-driven way to make decisions in health. SOPHiA GENETICS (Nasdaq: SOPH), is a cloud-native software company and a leader in data-driven medicine. We are dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM Platform, a cloud-native platform, capable of analysing data and generating insights from complex multimodal data sets and different diagnostic modalities.
Your mission:
As a Quality Specialist youensures that the quality processes are well applied in the company and up to date with the regulation requirements.
Requirements
The value you add:
Continuous assessment of Quality activities and documentation
- Assure the Technical Release of the semi-finished and finished product in compliance to regulations, regulatory dossiers and product specifications.
- Review batch records and generate related quality certificates.
- Following deviations related to laboratory and manufacturing with the concerned functions.
- Following complaints investigations.
- Creation and Review GMP documents related to production area, preventive maintenance plan, SOPs and validation/qualification documentation
- Coordinate technical equipment maintenance activities with external contractors.
- Establish compilations and trending of GMP data.
- Evaluate any signal detection of potential product quality impact and participate to resolve significant quality issues.
- Assure a communication flow and collaboration with operations and other functions.
Support for Audit amp; use Lean Management approach
- Follow up on Quality findings detected during internal / external / customer audit’s
- Assist during external and internal audits
- Apply continuous improvement and lean management
- Update SOPs according to our daily activities
- Monitor and Improve quality KPIs
The experience you bring:
- Fluent in English
- 3 years of experience minimum in Quality Assurance
- Strong knowledge in ISO13485 and FDA QSR
- Master in scientific field (preferably in Biology, Biotech, Bioinformatics)
- A high attention to detail and ability to prioritize.
- Pro-active problem solver, working with projects to balance quality, cost, and timelines while remaining compliant.
- Ability and willingness to learn/ use new software applications. Experience with Veeva and/or Jira a plus.
Benefits
Benefits
You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we drive exponential growth.
Business recognition and accolades include:
- World's most innovative companies (Top 10)
- World's smartest companies (Top 50)
- 100 Best Places to Work in Boston
- Top 10 European Tech Startup - 2020
- Top 10 European biotechs startup to watch - 2021
- Top 25 East-Coast Biotech to watch - 2021
Plus, you will find:
- A flexible, friendly, and international working environment with a collaborative atmosphere
- Flexible working hours, including hybrid remote / on-site working model
- An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
- A fast-growing company with plenty of opportunity for personal growth and development
- A hard technical challenge to solve with exciting modern technology - cloud computing, Big Data, DevOps, machine learning
Location: Bidart - FR - Office-based, including 2 days remote working per week
Start: ASAP (or as agreed)
Contract type: Permanent in full-time
Application process
Apply now with your CV and any supporting information.
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 stakehol