Global QA Compliance Manager Biosimilars (d/f/m)

Sandoz

Holzkirchen

Job Summary/Purpose

Managing Global Sandoz Quality Assurance Compliance related activities for Sandoz Technical Operations with focus on Biopharmaceutical Manufacturing Facilities. Oversight and ensure that all aspects of the operational business comply with cGxP, legal and regulatory requirements, Sandoz Quality Manual and internal standards. To ensure implementation, follow up and completeness of the Quality Plan, Quality Compliance strategy and Quality reporting. To ensure that a proper escalation and quality incident management process is followed, cGMP-compliant Quality decisions are taken and systematic and sustainable CAPAs are defined and implemented. To ensure adequate Health Authority inspection preparation of all respective sites and continuous improvement and optimization of the quality systems is introduced across the platform.

Your Key Responsibilities
• Ensure and lead Global Compliance activities within the Sandoz Technical Operations Biosimilars platform, provide... More Detail

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