Quality Assurance Manager and Data Protection - Lyon e, France - AXOLTIS PHARMA

AXOLTIS PHARMA
AXOLTIS PHARMA
Entreprise vérifiée
Lyon e, France

il y a 1 semaine

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
Description

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 position.

He/She will supervise the CMC project manager.

Based in Lyon and reporting to the CEO, the Quality Assurance Manager / DPO ensures:


  • Quality Assurance activities:
You are responsible for regulatory compliance, as a sponsor of clinical studies

  • 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 according to the project plan
  • 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 (European Regulation 2016/679 of April 27, 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)
  • 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, CDI, Temps partiel

Lieu du poste :
En présentiel
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