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Associate Director, Clinical Quality Assurance AuditorCytokinetics • New York, New York, United States
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Associate Director, Clinical Quality Assurance Auditor

Cytokinetics
  • US
    New York, New York, United States
  • US
    New York, New York, United States
Apply Now

About

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 audit program to ensure comprehensive coverage of company‑sponsored trials and critical vendors. Analyze and manage audit program metrics and trends to identify key compliance risks and improvement opportunities; communicate findings to senior management. Lead inspection readiness activities for global health‑authority inspections, including mock inspections, SME training, preparation, and documentation review. Assist with the design and ongoing creation, management, and maintenance of quality plans and metrics. Oversee and coordinate with contract auditors on internal and external quality audits of clinical vendors and investigator sites. Assist with quality review of key clinical documents such as clinical protocol, ICFs, CSRs, case report forms, and clinical SOPs. Design and conduct GCP training for functional departments, acting as the primary trainer for the auditor program. Support maintenance and continuous improvement of the clinical quality management system (QMS), including SOPs, training, and compliance metrics. Provide mentoring and oversight to QA staff and foster a culture of quality and accountability across clinical teams. Represent CQA in assigned projects and study/program team meetings to address quality issues, identify and resolve them, and advocate for quality and regulatory compliance. Perform other CQA duties as assigned by management. Qualifications Bachelor’s degree in life sciences with 10+ years of progressive global quality/regulatory compliance experience in pharma, biotech, or medical device industries, with a hands‑on role in quality audits and quality systems. Current and strong working knowledge of, and ability to interpret/implement, United States Code of Federal Regulations and European regulations and guidance, including ICH‑GCP guidance requirements governing clinical research conduct and pharmacovigilance operations. Experience with electronic quality management systems and trial master file management. Auditor certification is preferred. Up to 60% travel may be required. Experience in managing or supporting clinical trial or drug‑safety‑related regulatory inspections is a plus. Ability to lead cross‑functional teams, independently prioritize work, and manage multiple priorities while maintaining quality and GCP compliance objectives. Ability to apply expertise and skills to contribute to and achieve Cytokinetics’ company objectives and principles in creative and effective ways. Perform other duties as assigned. Pay Range In the U.S., the hiring pay range for fully qualified candidates is $195,300–$227,850 per year. The base pay offered will take into account internal equity and may vary depending on geographic region, job‑related knowledge, skills, and experience. Equal Opportunity Employer Cytokinetics is an Equal Opportunity Employer.
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  • New York, New York, United States

Languages

  • English
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