Senior Clinical QA Auditor & Global Audit Lead

Cytokinetics, Inc.; United States; Remote; USD 195,300 - 227,850; Full time

Job summary

Cytokinetics, Inc. is looking for an Associate Director, Clinical Quality Assurance (CQA) Auditor, responsible for managing the audit program and ensuring compliance with GCP guidelines.

This role requires over 10 years of progressive experience in regulatory compliance within the pharmaceutical sector and involves overseeing critical audits to maintain high-quality standards across clinical operations. A competitive salary range of $195,300–$227,850 per year is offered.

Qualifications

• 10+ years of progressively responsible quality/regulatory experience in pharma or biotech.
• Auditor certification preferred.
• Up to 60% travel may be required.

Responsibilities

• Serve as the CQA audit program process owner and manage audit activities.
• Lead GCP audits and develop a risk-based global clinical audit program.
• Mentor and oversee QA staff for enhanced accountability.

Skills

Global quality/regulatory compliance

GCP audit management

Risk-based auditing

Leadership of cross-functional teams

Knowledge of U.S. federal regulations

Education

Bachelor’s degree in life sciences

Tools

Electronic quality management systems

Job description

Cytokinetics, Inc. is looking for an Associate Director, Clinical Quality Assurance (CQA) Auditor, responsible for managing the audit program and ensuring compliance with GCP guidelines.

This role requires over 10 years of progressive experience in regulatory compliance within the pharmaceutical sector and involves overseeing critical audits to maintain high-quality standards across clinical operations. A competitive salary range of $195,300–$227,850 per year is offered.