- Report compliance concerns to Global Clinical Quality Assurance Management
- Participate in Global Clinical Quality Assurance projects
- Respond and recommend solutions to compliance concerns
- Maintain knowledge of current regulatory / GCP requirements
- Support Regulatory inspections as directed by Senior Global Clinical Quality Assurance Management
- Facilitate and support Regulatory Agency inspections
- Author and/or contribute to Global Clinical Quality Assurance SOPs, standard audit checklists and templates
- Provide coaching / mentoring to staff by the development of educational programs
- Represent Global Clinical Quality Assurance at assigned area meetings to deliver compliance advice
- Provide GCP and compliance advice
- Participate in quality improvement initiatives throughout Research & Development
- Investigate suspected scientific misconduct
- Provide quality metrics to program teams
Qualifications & Experience:
- Bachelor's degree in appropriate discipline or equivalent
- Knowledge and experience of the pharmaceutical industry
- Knowledge of the theory and practice of Good Clinical Practice (GCP) and/or of Auditing in any discipline
- Knowledge and application of GCP and relevant regulatory requirements
- Knowledge of basic auditing principles
- Basic understanding of multiple domains of the Certified Information Systems Auditor or Certified
- Information Systems Security Professional or equivalent (EPQA)
- Second language
1st IT People Limited is acting as an Employment Agency and/or Employment Business
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