Quality Assurance Manager and Data Protection

il y a 7 jours

Lyon e, 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 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, 2016). 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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