Quality Assurance Manager and Data Protection Officer

il y a 3 jours

Lyon, Auvergne-Rhône-Alpes, France Axoltis Pharma Temps plein

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

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