Quality Systems Manager
Il y a 6 minutes
OverviewStragen 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 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.ResponsibilitiesKey ResponsibilitiesQuality Systems ManagementDevelop, implement, and maintain Corporate and local Quality Systems aligned with GMP/GDP and ICH Q10 guidelinesEnsure inspection readiness for QA aspects of the QMS at Stragen and its affiliatesAct as the QA Systems representative during audits by competent authorities or customersSupport affiliates to ensure compliance with corporate processes and local regulationsMonitor, interpret, and ensure timely implementation of applicable regulations, guidelines, and quality standardsAdditional Programs & ComplianceLead and coordinate key quality programs, including:Quality Management ReviewsQuality Risk ManagementSelf-inspections and Internal AuditsInspection readiness activitiesMaintain and approve SOPs, documentation, and training plansDefine and approve self-inspection and audit plans, including internal testingTrack and report quality and compliance KPIs to assess system effectivenessEnsure CAPA follow-up, including remediation plans from inspectionsDigital & System ValidationContribute to the implementation and validation of computerized systems (CSV) within QADrive continuous improvement initiatives to optimize digital quality systemsCollaboration & Quality CultureInteract effectively with internal departments, affiliates, and external stakeholders to implement and maintain the QMSAct as a reference for quality culture, providing guidance on GxP complianceSupport internal teams to ensure processes comply with internal procedures and GMP/GDP standardsRequirementsPharmacist 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 industrySolid knowledge of GxP, QA systems, audits/inspections, and French Public Health CodeStrong analytical, organizational, and project management skillsFluent English, written and spoken #J-18808-Ljbffr
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Quality Systems Manager
il y a 15 heures
Lyon, France Archimed Sas Temps pleinStragen 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...
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Quality Systems Manager
Il y a 15 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...
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Quality Systems Manager
Il y a 18 minutes
Lyon, Auvergne-Rhône-Alpes, France ARCHIMED Temps pleinStragen GroupStragenis 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...
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Quality Systems Manager
Il y a 11 minutes
Lyon, Auvergne-Rhône-Alpes, France ARCHIMED Temps pleinStragen GroupStragenis 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...
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