Google Cloud PlatformGCPGoogle CloudRisk Management
About this role
Role Overview
Adopt and implement the global Quality Management Plan within the scope of the assignment
Identify and assess risks through data review and quality control processes
Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery
Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program
Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance
Work closely with Quality Assurance and assigned business staff in case of suspected misconduct
Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives
Requirements
Bachelor's Degree
Minimum of 5 years' experience in a pharmaceutical, bio-pharmaceutical, or CRO, or equivalent
Minimum of 3 years' experience in Quality Role
Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes
Knowledge of National and International Regulations and Drug Development processes
Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations