Global Director, Clinical Quality Assurance

Cytokinetics; San Francisco (CA); On-site; USD 222,000 - 260,000; Full time

Job summary

Cytokinetics in South San Francisco, CA, is seeking a Director, Clinical Quality Assurance to oversee the Clinical QA department, establishing quality programs and ensuring global regulatory compliance across GCP, GLP, and GVP.

You will lead a team, develop strategies, drive risk-based audits, maintain inspection readiness, and partner with study teams to remediate gaps, with travel up to 10%.

Qualifications

• Experience in GCP/GCP-related disciplines with regulatory knowledge.
• Proven leadership in clinical quality assurance and audits.
• Ability to implement risk-based quality plans and improvements.

Responsibilities

• Develop the GCP QA organizational strategy and staff development.
• Lead and co-host GCP, GLP, GVP inspections and audits.
• Oversee risk-based audit programs and vendor/site quality reviews.
• Ensure study teams have QA oversight and remediation for gaps.

Skills

GCP regulations interpretation

Regulatory compliance leadership

Staff development and management

Risk-based auditing

Inspection readiness and hosting

Communication across teams

Education

Bachelor's degree in life sciences

Job description

Cytokinetics in South San Francisco, CA, is seeking a Director, Clinical Quality Assurance to oversee the Clinical QA department, establishing quality programs and ensuring global regulatory compliance across GCP, GLP, and GVP.

You will lead a team, develop strategies, drive risk-based audits, maintain inspection readiness, and partner with study teams to remediate gaps, with travel up to 10%.