Vacatures vanaf € 60.000

Leiden - Director Clinical Quality

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Leiden - Biotechnologie - Director - Crucell

Management of staff • Provide expert support to all peer organisations and Global Quality team.• Make a significant contribution to the introduction and continuous improvement of local and global Quality strategies, policies and procedures.• Ensure planning and execution of Crucell Clinical and Pharmacovigilance audit programmes• Build and manage collaborative working relationships with cross functional peers and provide input into Corporate Quality Systems • Analyze and escalate significant quality and compliance issues to global quality management in a timely manner• Provide leadership, direction, and guidance to address compliance risks. • Monitor compliance and effectiveness through trending, analysis, metrics, and reporting to senior management; monitor Key Performance Indicators (KPIs) and identify opportunities for continuous improvement (e.g., Management Review• Partner with cross functional organizations to resolve compliance issues and oversee the implementation of corrective and preventative actions• Ensure Inspection Readiness (GCP and PV); interact with the Regulatory agencies as required;• Prepare and oversee the department budget. Minimum Qualifications: Education: • University degree in Health Sciences or related fieldSpecific Knowledge: • A strong, ...


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