Cytokinetics, Inc.

Overview Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of pioneering scientific innovations in muscle biology. The Associate Director, Clinical Quality Assurance (CQA) Auditor will serve as the primary auditor for GCP/GLP/GVP audits and the primary process owner of the CQA audit program. The role will liaise and interface with internal and external stakeholders to assess and support GCP compliance with local and ICH-GCP guidelines, driving and maintaining quality standards and a regulatory‑compliance culture at Cytokinetics. Responsibilities Serve as the CQA audit program process owner and manage day‑to‑day audit program activities, including audit coordination, report reviews, response reviews, CAPA follow‑up, and audit closures. Serve as the principal lead auditor for GCP, GVP, and GLP audits of investigator sites, CROs, vendors, laboratories, and internal functional areas. Develop, implement, and maintain a risk‑based global clinical...