Director, Quality Control

Role: Lead and oversee Quality Control activities for both clinical and commercial biopharmaceutical products at Omeros, providing strategic direction and scientific leadership for QC operations across all development phases. Responsibilities: manage QC teams, ensure GMP compliance for in-process and release testing, oversee stability testing and data analysis, establish QC standards, and support regulatory filings. Partner with internal and external stakeholders to develop analytical methods, transfer and validate assays, and drive continuous improvement initiatives. Qualifications: PhD in Analytical Chemistry, Biochemistry, Biology, or related field; 10+ years of QC experience, preferably with biologics and small molecules; deep knowledge of GMP, ICH guidelines, analytical method development, validation, and stability testing; experience with regulatory inspections and external testing collaborations. High-Value: biopharma QC leadership, GMP compliance, biologics and small molecules, analytical method transfer, stability and expiry strategy, regulatory interactions. WorkSetup: hybrid, with occasional travel (~10%). Supervisory role managing a small team and contractors.