Life Sciences & Technology
| Quality Assurance & Quality Control
A BDN client is looking for a Quality Assurance (QA) Director to help prepare to begin their first clinical trial (Phase I Oncology study) and will need a QA Director to help to develop the necessary quality-related documentation, prepare for and perform due diligence, quality audits for the client’s vendors, CROs, and sites, provide expertise to identify and resolve quality issues, provide QA oversight to vendors, ensure GCP compliance, and other related activities. The first activity the consultant will perform is to prepare for a due diligence audit of the client’s primary CRO which would include performing a GCP compliance audit, cross-functional assessment, risk mitigation action plan, and develop a report along with presenting findings. The consultant would continue to be utilized for subsequent audits of various vendors and help with QA oversight and other QA related tasks.