Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL).
Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates.
The Company is also working on the identification of biomarkers to improve diagnosis and treatment of these underserved illnesses. Sensorion has launched three preclinical gene therapy programs, currently at preclinical stage, aimed at correcting hereditary monogenic forms of deafness caused by a mutation of the gene encoding for Otoferlin, hearing loss related to gene target GJB2 as well as Usher Syndrome Type 1 to potentially address important hearing loss segments in adults and children. The Company is potentially uniquely placed, through its platforms and pipeline of potential therapeutics, to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders, a significant global unmet medical need.
Sensorion is a public company listed in Euronext Growth market since 2015.
The Quality Assurance Officer F/M reports to the Regulatory Affairs & Quality Assurance Director.
The Quality Assurance Officer F/M ensures the deployment of the Quality policy and coordinates its implementation (organizational methods/processes/audits) for drug development activities with a lead role in Risk and Issue Management.
The Quality Assurance Officer F/M is a permanent position based in Montpellier or Paris.
Management of the quality system
- Identify, implement and maintain fit-for-purpose quality management and associated quality documentation;
- Develop and follow quality action plan, identify and mitigate potential quality risks consequences of environmental changes and escalate to management;
- Interact with Development Operations to ensure quality compliance across all aspects of drug development;
- Develop the various tools and indicators (monitoring, methodological, practical sheets, impact measurements, monitoring indicators, development of operational action plans, annual report);
- Manage quality issues with operations (OOS/ non-conformities/deviations/claims);
- Monitoring of QEHS regulations;
- Ensure traceability and archiving of quality documents.
- Assess effectiveness of the quality system by designing an audit program of internal and external compliance audits and applicable assessments:
- Plan and execute internal and external audits;
- Participate to audits and inspections;
- Maintain the audit schedule.
Information / Advice / Training
- Develop and maintain risk analyses, alert management in the event of a critical event;
- Perform regulatory intelligence of good practices (GMP, GLP, GCP, etc.) and quality standards applicable to activities;
- Drive awareness and training of the departments concerned with quality; response to internal and external questions concerning quality;
- Ensure that the various operating modes and procedures are simplified as much as possible to improve their proper application by all those involved.
- Bac +5 Life Science or Pharmacy or equivalent specialised in Quality Assurance
- Minimum 5 years’ experience in a similar position in healthcare industry, biotech or CRO;
- Strong knowledge of quality management systems and quality standards (ISO, ICH, GLP, GMP, GCP, international guidelines, GDPR);
- Knowledge of project management tools, strategic planning and cross functional execution;
- Excellent oral and written expression in French & English.
Position to be filled as soon as possible.