Medical Quality Assurance

Essential Duties and Responsibilities:

• Optimize the Quality Assurance function, ensuring that the PV & CT activities are conducted in compliance with regulatory requirements and industry standards.
• Global inspection activities, including inspection preparation and inspection management, in close collaboration with Corporate Quality Assurance and Compliance.
• Define and articulate the strategy for the overall philosophy, scope and key elements of oversight of GDP, GVP and GCP activities in alignment and close collaboration with CQA, including but not limited to training, audits, vendor/CRO quality management, compliance oversight, and regulatory intelligence.
• Ensure that the audit program effectively identifies gaps and risks in the quality management system for GDP, GVP and GCP-regulated activities.
• Create and maintain a quality culture of transparency and efficient communication of quality related matters to achieve and maintain the desired high state of quality.
• Working with internal and external partners, establish and monitor Quality goals and KPIs.
• Drive strategies for processes, standards, and systems that minimize compliance risk and operational inefficiencies and maximize a strategic level of standardization.
• Identify and communicate needs within supported functions for process improvement.

Education Background & Preferred Experience:

M.Pharm with 6-8 years experience in Pharmacovigilance & Clinical Trial Quality Assurance.