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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.
Job Responsibility:
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
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
Contribute to the implementation and validation of computerized systems (CSV) within QA
Drive continuous improvement initiatives to optimize digital quality systems
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