Emplois actuels liés à Quality Systems Manager - Lyon, Auvergne-Rhône-Alpes - ARCHIMED
-
Quality Systems Manager
Il y a 32 minutes
Lyon, Auvergne-Rhône-Alpes, France ARCHIMED Temps pleinStragen GroupStragen is an international pharmaceutical group specialized in the development, manufacturing, and commercialization of specialty medicines. Operating across multiple countries, Stragen combines an entrepreneurial culture with strong governance, quality standards, and regulatory compliance in a highly regulated environment.Reporting to the...
-
Sap Quality Management Consultant
Il y a 26 minutes
Lyon, Auvergne-Rhône-Alpes, France RED Global Temps pleinWe're looking for askilled SAP QM Consultantto support a major transformation project in the energy sector. You'll play a key role inquality processes, deployment activities, and overall solution readiness, working closely with another expert on a high‑impact programme. Role: SAP QM Consultant Location: Auvergne-Rhône-Alpes region Contract Length: 6...
-
Système de management HLS
Il y a 26 minutes
Lyon, Auvergne-Rhône-Alpes, France Free-Work Temps pleinPour l'un de nos clients, nous recherchons un(e) intervenant(e) en système de management afin d'accompagner la structuration et la formalisation de son organisation.La mission consiste à définir et mettre en place une architecture de typeHigh Level Structure (HLS)permettant d'harmoniser les processus, les responsabilités et les pratiques...
-
Product Manager
Il y a 22 minutes
Lyon, Auvergne-Rhône-Alpes, France Medpace, Inc. Temps pleinWe are seeking a dynamic and experienced Product Manager (Research Engineer) to lead the development and enhancement of our Core Lab Systems including Medical Imaging, Cardiovascular and Remote Biosensor Technology. This role will be pivotal in driving innovation and ensuring our platforms meet the evolving needs of our clinical trial sponsors....
-
IT Manager
Il y a 18 minutes
Lyon, Auvergne-Rhône-Alpes, France ArchiMed Temps pleinStragen GroupStragen is an international pharmaceutical group specialized in the development, manufacturing, and commercialization of specialty medicines. Operating across multiple countries, Stragen combines an entrepreneurial culture with strong governance, quality standards, and regulatory compliance in a highly regulated environment.Reporting to the...
-
Data Manager
Il y a 15 minutes
Lyon, Auvergne-Rhône-Alpes, France emagine Temps pleinSummaryUnlock the power of data while securing accountability, availability, quality, and compliance across the value chain.The primary objective of this role is to steer and execute multiple aspects of data governance and management within the Group.Main ResponsibilitiesAs the Data Manager, you will provide leadership in Data Management across various...
-
Senior UX/UI Designer
Il y a 26 minutes
Lyon, Auvergne-Rhône-Alpes, France EPAM Systems Temps pleinEPAM is seeking a talented and experiencedSenior UX/UI Designerto join an IT UX Team in Geneva. This is a full-time on-site position working closely with both EPAM and client teams. You will play a key role in maintaining and evolving the design system, translating business briefs into effective prototypes and designing user interfaces that meet business...
-
Embedded SW Engineering Manager I
Il y a 21 minutes
Lyon, Auvergne-Rhône-Alpes, France Netatmo Temps pleinCompany Description What we do? We develop groundbreaking, intuitive and beautifully-designed connected consumer electronics. Truly smart, our innovative products provide a seamless experience that helps users create a safer, healthier and more comfortable & eco-friendly home.We carefully design the mechanics, electronics and embedded software of all our...
-
Clinical Trial Manager
Il y a 19 minutes
Lyon, Auvergne-Rhône-Alpes, France Medpace Temps pleinMedpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in our Lyon office. Clinical Trial Managers with expertise in Immunology and Infectious Diseases are welcome to continue to work in their area of expertise. We provide remote flexibility...
-
Clinical Trial Manager
Il y a 21 minutes
Lyon, Auvergne-Rhône-Alpes, France Medpace, Inc. Temps pleinMedpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in Lyon. Clinical Trial Managers with expertise in Oncology/Cardiovascular/Endocrine/Metabolic are welcome to continue to work in their area of expertise or to expand to a new therapeutic...
Quality Systems Manager
Il y a 39 minutes
Stragen Group
Stragen
is an international pharmaceutical group specialized in the development, manufacturing, and commercialization of specialty medicines. Operating across multiple countries, Stragen combines an entrepreneurial culture with strong governance, quality standards, and regulatory compliance in a highly regulated environment.
Reporting to the Head of Quality, the QA Systems expert leads the implementation and continuous improvement of Corporate and local Quality Management Systems (QMS). This role focuses on strategic QA systems, compliance, and inspection readiness, with limited operational urgency, offering high autonomy and exposure to corporate and affiliate environments.
This role is a
fixed-term contrat
(approx. 10 months), with a starting date in February 2026.
Key Responsibilities :
Quality Systems Management
- Develop, implement, and maintain Corporate and local Quality Systems aligned with GMP/GDP and ICH Q10 guidelines,
- Ensure inspection readiness for QA aspects of the QMS at Stragen and its affiliates,
- Act as the QA Systems representative during audits by competent authorities or customers,
- Support affiliates to ensure compliance with corporate processes and local regulations,
- Monitor, interpret, and ensure timely implementation of applicable regulations, guidelines, and quality standards
Quality Programs & Compliance
Lead and coordinate key quality programs, including:
Quality Management Reviews,
- Quality Risk Management,
- Self-inspections and Internal Audits,
Inspection readiness activities,
Maintain and approve SOPs, documentation, and training plans,
- Define and approve self-inspection and audit plans, including internal testing,
- Track and report quality and compliance KPIs to assess system effectiveness,
- Ensure CAPA follow-up, including remediation plans from inspections
Digital & System Validation
- Contribute to the implementation and validation of computerized systems (CSV) within QA,
- Drive continuous improvement initiatives to optimize digital quality systems
Collaboration & Quality Culture
- Interact effectively with internal departments, affiliates, and external stakeholders to implement and maintain the QMS,
- Act as a reference for quality culture, providing guidance on GxP compliance,
- Support internal teams to ensure processes comply with internal procedures and GMP/GDP standards
Requirements
- Pharmacist or scientific degree (Engineer, Master in Pharmaceutical Quality / Regulatory Affairs) - not mandatory if strong pharma experience;
- 7-8 years in QA within pharmaceutical or life sciences industry;
- Solid knowledge of GxP, QA systems, audits/inspections, and French Public Health Code;
- Strong analytical, organizational, and project management skills;
- Fluent English, written and spoken
