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Quality Assurance Manager and Data Protection Officer
Il y a 21 minutes
Axoltis Pharma is a biotechnology company specialized in the treatment of neurodegenerative and traumatic diseases of the central nervous system.
With a strong ambition to accelerate our development, we are now looking for a
Quality Assurance Manager and Data Protection Officer (DPO),
on a full time or part time (4/5) position.
Job Description
Based in Lyon and reporting to the CEO, the Quality Assurance Manager / DPO ensures:
Quality Assurance activities:
Maintain and update the Quality Management System
- Participate in the continuous improvement process by:
- Coordinating Deviation, OOS, Change Control or CAPA
- Perform / ensure the carrying out of internal and external audits as agreed in the annual audit plan. Manage any for cause audit, if needed
- Quality management of suppliers
- For preclinical activities, audit of protocols and reports
- For clinical activities, review clinical documentation
- In case of Inspection or third part audits, you will be the main contact
- Train departments to Quality Assurance activities
Review or supervise the regulatory watch
Data Protection activities:
Ensure Axoltis Pharma's compliance with the GDPR. To achieve this, all of the following tasks, will be carried out:
- Inform and raise awareness, disseminate a data protection culture
- Ensure compliance with the legal framework
- Inform, recommend, and alert if necessary, the data controller
- Analyze, investigate, audit and control contracts (if applicable), clinical documents
- Establish and maintain accountability documentation concerning data processing (DPIA, LIA, treatment log, MR conformity …)
- Mediate with data subjects any complaint or right request
- Present an annual report to the data controller
- Interact with the supervisory authority (CNIL)
Profile
- Master II in Quality Assurance for pharmaceuticals products or PharmD
- Experience in Data Protection in the clinical trials field.
- 5 years' experience in a biotech company as Quality Manager and in Data Protection
- Strong knowledge of regulation (GLP, GMP, GCP, GDPR)
- Good knowledge of computer tools,
- Fluent in English
Relational skills
Organization, analysis skills, ability to synthesize, teamworking, flexibility, force of proposals and communication skills are necessary to succeed in this position.
Reliable, honest, with a strong sense of confidentiality.
Interpersonal skills and a sense of pedagogy will enable you to effectively mobilize all the actors involved to collectively achieve the expected results.
Type d'emploi : Temps plein
Statut : Cadre
Rémunération : 50 000,00€ à 60 000,00€ par an
Lieu du poste : En présentiel
