<p><a href="https://himalayas.app/companies/cytokinetics">Cytokinetics</a> is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.</p><p>As the Associate Director, Clinical Quality Assurance (CQA) Auditor will serve as the primary auditor for GCP/GLP/GVP audits and primary process owner of the CQA audit program. This role will liaise and interface with internal and external stakeholders to assess and support GCP compliance with local, ICH-GCP guidelines and applicable regulations to drive and maintain quality standards and regulatory compliance culture at <a href="https://himalayas.app/companies/cytokinetics">Cytokinetics</a>. The ideal candidate has a quality mindset in global clinical development and oversees quality activities including but not limited to leading and conducting internal and external audits, representing CQA during inspection readiness with a proven ability to manage multiple complex projects. You will lead, execute, and manage Clinical QA activities while being an advocate to drive quality and regulatory compliance culture at <a href="https://himalayas.app/companies/cytokinetics">Cytokinetics</a>.</p><p>This is an excellent opportunity to help enhance quality culture while having a direct impact on our late and early-stage clinical trials that are the future of <a href="https://himalayas.app/companies/cytokinetics">Cytokinetics</a> growth!</p><h3>Responsibilities</h3><ul><li>Serve as the CQA audit program process owner and accountable for the day-to-day activities of the audit program, including audit coordinating, report reviews, response review, and CAPA follow up, and audit closures.</li><li>Serve as the principal lead auditor for GCP, GVP, and GLP audits, including investigator sites, CROs, vendors, laboratories, and internal functional areas. develop, implement, and maintain a risk-based global clinical audit program, ensuring comprehensive coverage of company-sponsored trials and critical vendors.</li><li>Analyze and manage audit program metrics, trends to identify key compliance risks and improvement opportunities; communicate findings to senior management.</li><li>Lead inspection readiness activities for global health authority inspections, including mock inspections, SME training and preparation, and documentation review.</li><li>Assist with the design and the creation/management/maintenance of quality plans and metrics.</li><li>Oversee and coordinate with contract auditors on internal and external quality audits of clinical vendors and investigator sites.</li><li>Assist with quality review of key clinical documents (e.g. clinical protocol, ICFs, CSRs, case report form) and clinical SOPs.</li><li>Design and conduct GCP Training for functional departments, act as the primary trainer for the auditor program.</li><li>