I'm working with a major global research‑driven pharmaceutical company best known for its work in neurology and oncology. They are looking for an Associate Director, Quality Assurance to join their team on a permanent basis.
The successful candidate will oversee GCP activities, CROs and Investigator Sites, lead GCP audits and inspection management activities; will ensure high quality execution of clinical trials from first in human through commercial marketing authorizations; will manage cross functional relationships and be the Lead Quality Assurance representative with both internal and external stakeholders. This is a high visibility position with great impact potential.
Main duties/responsibilities
* Representing CQA at internal, cross functional team meetings
* Supporting the training and development of CQA colleagues
* Proactively provide GCP QA support for clinical development activities to protect patient safety & well being, maintain data integrity, and support operational excellence
* Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and Vendor/System audits
* Acting as CQA Lead for clinical studies, drafting and managing Audit Plans and Audit reports
* Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
If this is something you would be interested in exploring send your CV to jamie.keith@cpl.com