As the Associate Director, Clinical Quality Assurance (CQA), you are a key member of the Clinical Quality team maintaining representing Clinical QA in cross functional setting, and advising Cytokinetics Clinical Operations, Biometrics, Drug Safety and Pharmacovigilance teams on GCP matters. 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 representing CQA on clinical study teams, inspection readiness, internal and external audits 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 enhance quality culture while having a direct impact on our late and early-stage clinical trials that are the future of Cytokinetics growth!

Responsibilities

Responsibilities include Clinical Quality Assurance (CQA) lead to ensure Good Clinical Practice (GCP) compliance and the quality of all deliverables including:

• Provide CQA oversight to Phase I-III global clinical studies to ensure study conduct compliance in accordance with GCP, applicable regulatory requirements, study protocols and Cytokinetics procedures.
• Accountable for inspection readiness activities including collaborating with cross functional and clinical site Inspection Readiness/Preparedness activities.
• Lead audits, or co-audit GCP vendors and clinical sites
• Provide expert CQA guidance and strategic coaching to stakeholders (e.g. Clinical Research, Clinical Operations, Data Management, Pharmacovigilance) to support regulatory inspections.
• Design and implement the creation/management/maintenance of quality plans and metrics.
• Collaborate with staff conducting internal and external quality audits of clinical vendors and investigator sites.
• Perform quality review of key clinical documents (e.g. clinical protocol, ICFs, CSRs, case report form) and clinical SOPs.
• Design and conduct GCP Training for functional departments.
• Represent CQA in assigned projects and study/program team meetings to address quality issues that may arise, including identification and resolution and be an advocate for quality and regulatory compliance.
• Other CQA duties as assigned by management

Qualifications

• Bachelor's degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred
• Current and strong working knowledge, interpretation/implementation 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.
• Auditor certifications a plus.
• Up to 10% travel may be required.
• Experience in managing or supporting clinical trial or Drug Safety-related regulatory inspections a plus.
• Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP compliance objectives.
• Ability to use expertise and skills to contribute and achieve Cytokinetics’ company objectives and principles in creative and effective ways.
• Other duties as assigned.