Quality Systems Manager
il y a 13 heures
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 contract (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. Qualifications 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. #J-18808-Ljbffr
-
Quality Systems Manager
Il y a 4 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...
-
Quality Systems Manager
il y a 14 heures
Lyon, France ARCHIMED Temps pleinOverviewStragen Group 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...
-
Supplier Quality Manager
il y a 2 semaines
Lyon, France Symbio Temps plein**Symbio is hiring !** Welcome to Symbio, we are one of the future major actors of the clean mobility, zero emission ! Our company creates hydrogen systems which are incorporated on different types of vehicles (cars, trucks, boats ). We are now expanding our activities and we are in a hyper-growth phase ! Established in 2010, Symbio is now a joint venture...
-
QA Systems Lead
il y a 14 heures
Lyon, France ARCHIMED Temps pleinAn international pharmaceutical company is looking for a QA Systems expert to lead the improvement of Quality Management Systems. The role requires 7-8 years in QA and a strong understanding of GxP standards. You'll develop and implement quality systems, ensure compliance, and support inspection readiness. The position offers high autonomy and requires...
-
Regulatory and Quality Manager
il y a 2 jours
Lyon 7e, France Dr. Schär France Temps pleinIn 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,...
-
Quality Director
il y a 1 semaine
Lyon, France Adler Pelzer Group Temps pleinThe **Adler Pelzer Group** is a worldwide leader in the design, engineering and manufacturing of acoustic and thermal components and systems for the automotive sector. With more than 15,000 employees and approximately 100 manufacturing and R&D facilities, we deliver to all major car brands globally. **Quality Director, multi-site** Defining and...
-
Quality Engineer
il y a 2 semaines
Lyon, France American Axle & Manufacturing Temps pleinAt AAM, the POWER is in our people. We believe that an equitable and inclusive workplace benefits everyone and that the diversity of our Associates drives creativity and innovation. Our global team of associates is made of dreamers, doers and innovators who are Bringing the Future Faster by Delivering POWER for a safer, brighter and more sustainable...
-
Quality Assurance Intern
il y a 2 jours
Lyon, France AUROBAC THERAPEUTICS Temps plein**Become part of a team of 30 employees, united by strong values: excellence, shared vision, team spirit and respect. In a dynamic and multicultural environment, you will contribute to impactful projects while developing your skills. AUROBAC THERAPEUTICS offers a professional setting that fosters growth, engagement and continuous development. Let’s build...
-
Product Quality Engineer
il y a 14 heures
Lyon, France LEM Temps pleinAt LEM, we help our customers and society accelerate the transition to a sustainable future.Our global team of 1,700 professionals which spans over 15 countries is dedicated to converting technology potential into powerful solutions, which enable the decarbonization of the world.A leading company in electrical measurement, LEM engineers the best solutions...
-
Quality Assurance and Regulatory Affairs France
il y a 1 semaine
Lyon, France Valneva Temps pleinThe Pharmaceuticals Affairs intern supports pharmaceuticals affairs activities of Valneva France SAS as defined in article R.5124-2-3: Quality assurance, Wholesaling, Advertising, Regulatory Affairs. All activities are performed under the Pharmacien Responsable supervision. **Responsibilities**: > Exploitant/Distributor Quality Assurance › Support...