Principal, Quality Assurance

Role: Principal, Quality Assurance at a clinical-stage biopharma developing next-generation CAR T-cell therapies for solid tumors and hematologic malignancies. Primary objectives include providing quality oversight across the product lifecycle, supporting process validation, technology transfer, and regulatory submissions. Responsibilities encompass leading process validation activities for lentiviral vectors, plasmids, and drug products, ensuring GMP compliance, reviewing validation documentation, and collaborating with CDMOs, Process Development, and MSAT teams. The role also involves serving as the QA SME for IND and BLA preparations, authoring and reviewing regulatory documentation, and ensuring inspection readiness. Requirements include a minimum of 15 years in biochemistry, chemical engineering, or related fields, with 10-15 years of GMP biopharma experience, including 4+ years in cell therapy or viral manufacturing, and at least 5 years in QA. Preferred qualifications feature experience supporting BLA submissions, regulatory inspections, and post-approval lifecycle management. High-value specifics include expertise in cell therapy, lentiviral vector manufacturing, GMP clinical operations, and working within GxP environments. The position partners closely with cross-functional teams, reports to senior management, and may require shift, weekend, and holiday work. Based in Bothell, Washington, with the potential for flexible work arrangements.