HDT Global

QA Engineer

• Ensuring robust quality assurance systems and procedures are in place for pre-clinical activities through clinical trial operations
• Ensuring non-clinical and clinical study execution are compliant with applicable GLP, GCLP, and GCP regulatory requirements
• Regulatory compliance oversight of both internal functions and outsourced activities through audit activities
• Collaborating with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, Bioanalytical and Preclinical functions
• Developing/improving quality programs and procedures
• Overseeing/approving clinical and regulatory documentation
• Evaluating internal systems and external clinical sites and vendors for compliance
• Providing QA support for risk assessment and remediation
• Developing and delivering training on good clinical practice concepts

Senior Director, GCP, GLP QA