QUALITY ASSURANCE/COMPLIANCE

Audit & CAPA Lead

Key responsibilities: Audit & CAPA process owner On behalf of the Head of Quality, act as business owner for “Audit & CAPA System”: single point

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Quality Management Systems (QMS) Team Lead, (Associate) Director

Act as a strategic driver to build and implement a sustainable transversal QMS Procedural Document (ProcDoc) / Training Framework driving the day-to-day GxP development activities
Evaluate operations from a strategic level to ensure that the QMS consistently meet quality and regulatory requirements from a Procedural Document and Training perspective

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Head of Clinical Compliance

Act as a strategic driver to evaluate, optimize and implement the pro-active, fit-for-purpose and risk-based Clinical Quality Strategy ensuring compliance during the day-to-day clinical drug development activities. Drive the quality culture and create quality awareness throughout the clinical development organization

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Global Senior Manager, Procedural Document & Training Quality Lead

Procedural Document Management. Evaluate, design, optimize & implement the DPI Procedural Document (ProcDoc) Strategy in alignment with business objectives. Partner with critical quality & business representatives to drive the newly Quality Management System (QMS) module, more specifically Procedural Document Management System..

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Clinical Development Quality Lead

Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5)…

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