Director of Quality Assurance, Clinical

Role: Lead clinical quality assurance for GCP, GLP, and PV activities within a cell and gene therapy biopharma company. Objectives include developing and maintaining QA systems, ensuring compliance with international regulations (ICH-GCP, ICH-PV, FDA, EU), and supporting clinical trial integrity. Responsibilities encompass overseeing audits of vendors and sites, reviewing documentation, managing inspection readiness, and enhancing quality management systems. Qualifications: ≥15 years in clinical QA, with deep expertise in GCP, GLP, PV, and biologics or cell/gene therapy industries; strong knowledge of US regulations, ICH guidelines, and audit strategies. Preferred: experience with GLP studies, certification in QA or GCP, and prior biologics oversight. High-Value: senior leadership role in a clinical-stage biotech focused on off-the-shelf, allogeneic cell therapies targeting hematologic malignancies and autoimmune diseases; involvement in regulatory inspections and process improvements; travel up to 25-30%; based in Berkeley, CA, or remote.