Upvote
Downvote
Director / Senior Director, Clinical Quality Assurance
Share Job
- Suggest Revision
- Annexon Biosciences seeks a Quality Assurance (QA) Director/Senior Director to lead the company's clinical Quality Assurance (cQA) program.
- Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of the Annexon product pipeline.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities.
- Undergraduate or graduate degree(s) in Pharmaceutical Sciences, Chemical Engineering, or related discipline with at least 10 years of experience in clinical quality assurance in biotechnology and/or pharmaceutical industry.
- Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits.
Active Job
Updated TodaySimilar Job
Relevance
Active