Senior Quality Cluster Lead – Western Europe

Santen

Paris

On-site

EUR 112,000 - 154,000

Full time

6 days ago

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Job summary

Santen is a specialized ophthalmology company seeking a Senior Quality Cluster Lead Western Region/Responsible Pharmacist to oversee quality across France, Iberia and Italy, ensuring GMP, GDP and GVP compliance with local regulations. You will be the primary quality interface between Manufacturing, Distribution and Commercial Operations and uphold a culture of patient safety and continuous improvement.

Your responsibilities include leading the Quality Management System, coordinating audits,

Qualifications

Doctor of Pharmacy or qualified pharmacist with extensive multinational pharma experience.
In-depth knowledge of EU GMP, GDP and GVP principles.
Experience with Exploitant operations in France.
Audits, inspections, and regulatory liaison experience.
Fluent in French and English.

Responsibilities

Lead Quality oversight across France, Iberia and Italy and ensure an effective Quality Management System.
Act as the Quality subject matter expert for regulatory requirements and translate them into business needs.
Ensure inspection readiness and represent the company in health authority interactions.
Oversee quality risks, deviations, complaints, recalls and CAPAs with effective corrective actions.
Provide Quality leadership for new product launches and distribution changes.
Collaborate with Regulatory Affairs, Pharmacovigilance, Medical Affairs, Supply Chain and others.