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Job description :
Responsibilities:
• Responsible for managing the integration of quality into business processes by simplifying and improving targeted clinical trial activities, working closely with local and global functional groups in the US and Europe.
• Participates in the development of quality controls, evaluates procedures, and analyses metrics enhancing overall quality.
• Oversight of training administration.
• Acts as the key liaison / coordinator for internal audits and regulatory inspections.
• Evaluates and assesses third party organizations in Singapore and Asia Pacific region.
• Develops and implements a quality strategy and quality plan.
• Develop regular progress improvement metrics and reports and chairs quality governance meeting.
• Oversight of SOP system, and assists in the development of SOPs.
• Effectively partnering with personnel to identify performance gaps relative to current regulations, and provides technical expertise for integrating quality into business practices
• Serves as a liaison with the organization’s personnel to assure quality plans/goals/initiatives are understood and compliance with required procedures and training.
• Monitors external regulatory local and global environment, evaluates local impact and where possible influence draft changes. Leads implementation of any new regulations
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