Director, Quality Systems
$225k - $262.5kCytokinetics
Cytokinetics seeks a Director of Quality Systems to lead quality management, document control, and GxP training functions. The role provides strategic oversight of quality systems operations, regulatory compliance, and team development within a specialty cardiovascular biopharmaceutical company.
Responsibilities
- Provide strategic direction for Quality Systems organization and oversee QMS, document control, and GxP training groups
- Lead, mentor, and develop Quality Systems teams while managing performance and career progression
- Ensure quality systems comply with FDA, EMA, ICH, and GxP regulations and maintain continuous improvement
- Oversee document control program and GxP training curricula across the company
- Establish metrics, dashboards, and lead inspection readiness activities for quality system health
Requirements
- Bachelor's degree in life sciences
- 12+ years biopharmaceutical industry experience
- 7+ years leading Quality Systems in regulated life sciences
- 5+ years progressive people management experience
- Strong QMS, CAPA, Change Control, and Deviation expertise
- In-depth knowledge of quality principles and industry standards
- Veeva Quality Vault experience preferred
Compensation: $225,000 - $262,500 base salary
Vacancy posted 5 days ago
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