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Associate Director, Clinical Quality Assurance Auditor

Cytokinetics · US

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, a...

Job description

Cytokinetics 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. 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 Cytokinetics. 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 Cytokinetics. This is an excellent opportunity to help enh...