Description
Omeros is hiring a Clinical QA Manager/Senior Manager to provide quality and compliance oversight for clinical trials within its Regulatory Quality Assurance team. The role includes strategic QA planning, CRO and service-provider qualification, GCP audits, audit findings and CAPA oversight, root-cause analysis, quality metrics, SOP development, clinical-team guidance, training, and regulatory inspection support. Candidates need a science university degree, at least 8 years of GCP/clinical quality assurance experience including 3 years of GCP auditing, strong knowledge of GCP, GLP, and ICH requirements including ICH E6(R3), excellent communication and organizational skills, and willingness to travel 25–35%.
