Associate Director, Clinical Quality Assurance Auditor

Role Summary

Associate Director, Clinical Quality Assurance (CQA) Auditor serves as the primary auditor for GCP/GLP/GVP audits and the process owner of the CQA audit program. The role liaises with internal and external stakeholders to assess and support GCP compliance with local, ICH-GCP guidelines and applicable regulations to drive quality standards and regulatory compliance culture at Cytokinetics. The ideal candidate maintains a quality mindset in global clinical development and leads and conducts internal and external audits, represents CQA during inspection readiness, and manages multiple, complex projects. You will lead, execute, and manage Clinical QA activities and advocate for quality and regulatory compliance throughout Cytokinetics.

Responsibilities

• 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, CAPA follow up, and audit closures.
• 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.
• 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 and preparation, and documentation review.
• Assist with the design and the creation/management/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 (e.g. clinical protocol, ICFs, CSRs, case report form) and clinical SOPs.
• Design and conduct GCP Training for functional departments, act 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 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 quality audits 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 certification is preferred.
• Up to 60% 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.

Skills

• GCP/GVP/GLP auditing
• Quality management systems (QMS) and Trial Master File
• Inspection readiness and regulatory inspections
• Quality documentation review and SOP development
• Training design and delivery; mentorship of QA staff
• Cross-functional leadership and project management
• Data analysis and metrics for risk-based auditing

Education

• Bachelor's degree in life sciences

Additional Requirements

• Up to 60% travel may be required.