Quality Assurance Manager and Data Protection

Il y a 7 mois


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



  • Lyon 7e, France AUROBAC THERAPEUTICS Temps plein

    **PRESENTATION OF THE COMPANY** AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux. Dedicated to addressing high unmet medical needs associated with infections in acute hospital settings, amidst the growing antimicrobial resistance...


  • Lyon 7e, France Dr. Schär France Temps plein

    In our 18 sites in eleven countries, we work for our mission and a global market. All over the world, people with special nutritional requirements trust in the expertise of Dr. Schär. The French medical division includes two Business Units (Renal and Gluten-Free). With a growing company and business, for our site located in Lyon with a permanent contract,...


  • Lyon, France Bandai Namco Europe Temps plein

    Lyon (69) Position Duties As a Quality Assurance Project Manager within the Production Services department, you will be part of the Quality Assurance team. Under the supervision of the Quality Assurance Manager, you will manage the quality control efforts on allocated titles. This includes functionality and compliance testing activities, the follow-up of...


  • Lyon, France Bandai Namco Europe Temps plein

    Bandai Namco Europe is a leading global publisher and developer of entertainment content for platforms including all major video game consoles and PC. BNEU is the western content hub of Bandai Namco Entertainment Inc.(BNEI), and is building its reputation with franchises such as LITTLE NIGHTMARES, THE DARK PICTURES ANTHOLOGY, and the upcoming UNKNOWN 9...


  • Lyon 7e, France AUROBAC THERAPEUTICS Temps plein

    **PRESENTATION OF THE COMPANY** AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux. Dedicated to addressing high unmet medical needs associated with infections in acute hospital settings, amidst the growing antimicrobial resistance...


  • Lyon, France BI AH France SCS Temps plein

    **Position Area**:I-1 **Position Location**:Boreal **Type of contract**:Permanent contract **Schedule**:Day schedule **Our company**: **At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.** **Now, we are...


  • Lyon, France Dr. Schär Temps plein

    In our 18 sites in eleven countries, we work for our mission and a global market. All over the world, people with special nutritional requirements trust in the expertise of Dr. Schär. The French medical division includes two Business Units (Renal and Gluten-Free). With a growing company and business, for our site located in Lyon with a permanent...


  • Lyon, France Amazon France Transport SAS Temps plein

    Master’s Degree - Operational experience - Proven track record of senior stakeholders engagement - Advanced excel and data analysis skills - Experience in program management, customer research and analytics, and/or customer experience/success - Fluent in French and English You want to develop yourself in a team that leads complex and business critical...


  • Lyon, France New Tales Temps plein

    This is a fantastic opportunity to join one of most exciting game studios, using leading technology to create new genre-defining games, within our collaborative Action RPG team. New Tales is currently looking for a highly motivated and talented **Quality Assurance Analyst (F/M) in freelance contract **to join our adventure at NEW TALES. **WHAT IS THE JOB...


  • Lyon, France HM CLAUSE Temps plein

    **Type de contrat**: CDI **Temps de travail**: Temps complet **Famille de métier**: PRODUCTION ET OPERATIONS - CONTRÔLE QUALITE **Finalité du poste**: The QC Regional Manager plays a crucial role in the strategic development and execution of operations within the Quality Control (QC) department. As a key member of the QC leadership team, the incumbent...

  • Clinical Data Manager

    Il y a 4 mois


    Lyon, France Amaris Consulting Temps plein

    Job description We are seeking a skilled and dedicated Clinical Data Manager to join our team at Amaris Consulting - CRO. As a Clinical Data Manager, you will be responsible for overseeing the data management activities for clinical trials and research projects. You will work closely with cross-functional teams to ensure...

  • Quality Manager

    Il y a 6 mois


    Lyon, France Hyperion Materials & Technologies Temps plein

    **Summary**: In this key role, The Operations Area Quality Manager is responsible for the overall coordination of the Quality processes with the customer and within the production facilities in their areas of responsibility. Responsible for developing, implementing and administering policies and procedures to achieve the Customer Satisfaction and ensure...

  • Alternance Bac +4/+5

    Il y a 6 mois


    Lyon, France Group Trucks Purchasing Temps plein

    Alternance Bac +4/+5 - Data Analyst - H/F **Location**:Lyon, FR, 69802**Position Type**:Student- Transport is at the core of modern society. Imagine using your expertise to shape sustainable transport solutions for the future? If you seek to make a difference on a global scale, working with next-gen technologies and the sharpest collaborative teams, then we...

  • Data Manager

    Il y a 6 mois


    Lyon 8e, France Complife France Temps plein

    **Description du poste **:Data-manager / Biostatisticien Senior Complife France est une société composée de deux centres (Brest et Lyon) qui fait partie du groupe international COMPLIFE. Prestataire de service pour l’industrie du bien-être et de la beauté, Complife France évalue la tolérance, la sécurité et l’efficacité de produits...


  • Lyon, France Volvo Group Temps plein

    France **Position Description** **Position Description** With new technologies and business models increasing in importance at high speed, the transportation and infrastructure industries are changing more and at higher pace than ever before. As the Volvo Group, we are accelerating to drive our industry forward also in these important areas. Do you want...


  • Lyon, France Recordati Group Temps plein

    With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we...


  • Lyon, Auvergne-Rhône-Alpes, France GLO Comms Temps plein

    We are looking for an experienced Azure Data Engineer to join our team at GLO Comms in Lyon, France.As an Azure Data Engineer, you will play a key role in designing and implementing business intelligence (BI) and analytics solutions using Microsoft tools such as Power BI and Azure Data Factory.About the RoleCollect and understand project requirements to...


  • Lyon, France Bayer Temps plein

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Quality Technician

    Il y a 7 mois


    Lyon, France RENISHAW Temps plein

    A vacancy has arisen for a Quality Engineer (maternity cover) based in Renishaw Mayfield, a French subsidiary of Renishaw Neuro Solutions Ltd, in Chassieu. **Main responsibilities**: - Maintain the quality management system in accordance with the ISO 13485 standard and 21CFR Part 820 Quality System Regulation. - Day to day maintenance of the QMS in...

  • Qhse Data

    Il y a 6 mois


    Lyon, France HM CLAUSE Temps plein

    **Type de contrat**: CDI **Temps de travail**: Temps complet **Famille de métier**: FONCTIONS SUPPORT - MANAGEMENT DES RISQUES ET DE LA QUALITE **Finalité du poste**: Reporting directly to the Director of Global QHSE & CSR, you will be responsible for the entire QHSE management system platform, data and reporting. **Vos Missions**: If you want to join...