Quality Systems Manager

il y a 7 heures

Lyon, Auvergne-Rhône-Alpes, France ArchiMed Temps plein

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.

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