Manager II, Clinical Quality Assurance
Tarsus Pharmaceuticals, Inc. · Irvine, California, US
Reporting to the Director of Clinical Quality Assurance, the Manager II, Clinical Quality Assurance, is responsible for clinical quality support and manageme...
Job description
About the Role Reporting to the Director of Clinical Quality Assurance, the Manager II, Clinical Quality Assurance, is responsible for clinical quality support and management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) supplier qualification program. The successful candidate will assist in inspection readiness activities across the company, training and ensuring adherence with current ICH GCP E6 guidance and applicable regulations. Let’s talk about some of the key responsibilities of the role: - Provide day-to-day clinical quality support and training, as appropriate, to ensure adherence with applicable regulatory requirements, company policies and procedures. - Coordinate all GCP/GLP/GVP related internal and supplier audit activity including management and maintenance of the qualification program’s audit schedule within the Quality Management System (QMS). - Perform supplier audits and prepare author reports, as needed. - Compile audit responses and review implementation evidence. - Support the implementation of quality systems and processes within the Clinical Quality area. - Review and approve QMS records (deviati...