Summary

•Improved quality of outputs
•Increased compliance with SOP, GCP and training
•Decreased audit/inspection findings
•Efficient use of resources through operational effectiveness

About the Role

Key responsibilities:

• Responsible for ensuring operational excellence related to clinical trial activities within TCO. Track progress to key quality indicators (KQIs), Quality Plan and overall compliance to applicable processes and regulations. Lead and assist in the development and implementation of process improvement initiatives within the function; ensure changes are adequately communicated and managed.
• Work collaboratively with CQA and appropriate line functions to ensure that TCO upholds high quality standards.•Accurate and timely execution of process improvement and quality initiatives as measured by meeting key milestones effectively.
• Successful implementation of process improvements as measured by sustainable changes and improved efficiency.
• Increased compliance with relevant processes.
• Establish business partnerships with all relevant TCO functional groups, CQA, training and other LFs as required.
• Training programs implemented in a timely fashion, and tracked to ensure compliance and maintenance

Essential Requirements:

• BS or advanced degree in scientific discipline or equivalent education in life science/healthcare required

• A minimum of 5 years of relevant pharmaceutical clinical development experience
• Extensive knowledge of clinical development process, GCP and clinical quality management; including strong understanding of regulation and guidance for clinical studies
• Proficiency/Fluency in English
• Experience working in matrix environment and in global teams.
• Excellent interpersonal, problem-solving, negotiation and conflict resolution skills
• Excellent organizational skills, as well as predisposition to quality management and process improvement
• Excellent communicator and presenter (oral and written).

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