Director of Quality Systems & GxP Excellence

Regulatory Jobs; South San Francisco (CA); Hybrid; USD 225,000 - 263,000; Full time

Job summary

Cytokinetics is seeking a Director of Quality Systems to lead the quality management system, document control, and GxP training programs. You will provide strategic direction, develop a robust QMS, and ensure inspection readiness in alignment with cGMP standards.

The role requires extensive leadership experience in biopharma, with deep knowledge of CAPA, Change Control, deviations, and QMS analytics. Collaboration with IT for eQMS enhancements is essential.

Qualifications

• Lead and manage Quality Management Systems, CAPA, change control, deviations, and risk management.

Responsibilities

• Provide strategic roadmap for the Quality Systems organization, overseeing QMS, document control, and GxP training groups, and mentor staff.

Skills

Quality Management Systems

CAPA

Change Control

Leadership

Regulatory Compliance

Quality Metrics

Education

Bachelor's degree in life sciences

Tools

Veeva Quality Vault

Job description

Cytokinetics is seeking a Director of Quality Systems to lead the quality management system, document control, and GxP training programs. You will provide strategic direction, develop a robust QMS, and ensure inspection readiness in alignment with cGMP standards.

The role requires extensive leadership experience in biopharma, with deep knowledge of CAPA, Change Control, deviations, and QMS analytics. Collaboration with IT for eQMS enhancements is essential.