Associate Director, Clinical Quality Assurance Auditor

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, and 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, 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.

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.