Director, Quality Systems & Regulatory Compliance

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 225,000 - 263,000; Full time

Job summary

Cytokinetics, Inc. is seeking a senior leader to steer the Quality Systems organization, ensuring QMS governance, document control, and GxP training are effective and compliant.

The role emphasizes cross-functional collaboration, performance coaching, and strategic process improvements across the company. The ideal candidate has extensive experience in quality systems within regulated life sciences, with a proven track record in leadership, regulatory readiness, and data-driven quality

Qualifications

• Bachelor’s degree in life sciences with 12+ years in biopharmaceuticals.
• 7+ years leading Quality Systems within pharma/biotech/medical devices.
• Strong leadership and communication skills.
• Experience with QMS processes (CAPA, Change Control, Deviations, CI, QRM).
• Veeva Quality Vault experience preferred.

Responsibilities

• Provide strategic roadmap for Quality Systems, including QMS oversight and training groups.
• Lead and develop teams for document control and GxP training administration.
• Act as Business Process Owner of the QMS and ensure regulatory compliance.
• Develop metrics and dashboards to monitor quality system health.
• Lead inspection readiness activities and quality system projects.

Skills

Quality Management Systems

CAPA

Change Control

Deviations

Continuous Improvements

Quality Risk Management

Veeva Quality Vault

Education

Bachelor’s degree in life sciences

Tools

GxP systems

eQMS

Job description

Cytokinetics, Inc. is seeking a senior leader to steer the Quality Systems organization, ensuring QMS governance, document control, and GxP training are effective and compliant.

The role emphasizes cross-functional collaboration, performance coaching, and strategic process improvements across the company. The ideal candidate has extensive experience in quality systems within regulated life sciences, with a proven track record in leadership, regulatory readiness, and data-driven quality