Senior QA Quality Manager
You will be responsible for developing and maintaining a level of excellence in all our Tools4patient clinical QA activities. You will report to our CEO and work in partnership with our Tools4patient operational and scientific groups to assist with all the clinical-related activities conducted by Tools4patient on behalf of its sponsors’ clients or for its own R&D activities, globally and at all stages of drug development.
You will ensure that T4P activities are carried out in compliance with international requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations. You will be responsible for managing, conducting and/or participating in regional/global audits. You will use your technical expertise to identify and resolve quality issues.
The T4P Quality Management System
You will be responsible for the maintenance and future development of our T4P Quality Management System in line with our business activities (including software development). More specifically you will:
You will be responsible for providing unsupervised expert GCP advice to key personnel. This will include, but will not be limited to:
You will be responsible for preparing for regulatory inspections at T4P and/or partner sites across the region and worldwide. In particular, you will:
You will develop and manage communication between the QA departments of service providers for the purposes of QA oversight and mitigate any risks to T4P business.
Necessary prior experience
We can offer you: