Director, Quality Systems & Compliance — Hybrid

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

Benefits offered by this job

Stock options / RSUs

Comprehensive health insurance

Dental insurance

Vision insurance

Life and disability insurance

401k with employer match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics Incorporated in South San Francisco, CA, seeks a Director of Quality Systems to lead the quality management system, document control, and GxP training. You will shape strategy, mentor teams, ensure regulatory readiness, and partner with IT to enhance the eQMS across the organization.

You will guide cGMP compliance, oversee CAPA, Change Control, Deviations, and Quality Risk Management, and drive continuous improvement while ensuring inspection readiness and alignment with company

Qualifications

• Bachelor's degree in life sciences with 12+ years in biopharma, incl. 7+ years leading Quality Systems.
• 5+ years of progressive people-management experience incl. mentoring and developing Quality professionals.
• Demonstrated leadership with effective communication and teamwork to deliver results.
• Strong direct experience with QMS, including CAPA, Change Control, Deviations, and Quality Risk Management.
• Veeva Quality Vault experience preferred.
• Experience in a global, multi-site or international GxP environment preferred.

Responsibilities

• Provide strategic roadmap for the Quality Systems organization, incl. QMS, document control, and GxP training; oversight of teams.
• Lead and develop teams responsible for document control, GxP training administration, and quality system processes.
• Act as Business Process Owner of the QMS.
• Ensure Quality Systems and processes are maintained and updated to reflect best practices.
• Ensure QMS compliance with applicable FDA, EMA, ICH, GxP and other regulatory requirements.
• Oversee the document control program: review, approval, issuance, revision, archival, retrieval of GxP documents.
• Oversee the GxP training program: curricula, assignment, completion, and effectiveness.
• Collaborate with IT to implement updates/enhancements to the eQMS and provide system support.
• Lead company-wide quality systems projects across departments.
• Work with GxP functional leaders to implement processes supporting business operations and analytics.
• Monitor the entire quality system to maintain acceptable performance levels.
• Manage continuous improvement programs as required.
• Establish and report metrics and dashboards for quality system health and reviews.
• Review and approve cGMP records and documents as required.
• Develop and manage goals and budgets aligned with company vision.
• Address complex problems with strong judgment and cross-functional impact.
• Lead inspection readiness activities related to Quality Systems.
• Mentor and develop Quality Systems personnel and SMEs.
• Recruit talent and build a high-performing team.

Skills

Quality Management Systems

Leadership

Strategic thinking

Regulatory compliance

Communication

People management

Education

Bachelor's degree in life sciences

Tools

Veeva Quality Vault

Job description

Cytokinetics Incorporated in South San Francisco, CA, seeks a Director of Quality Systems to lead the quality management system, document control, and GxP training. You will shape strategy, mentor teams, ensure regulatory readiness, and partner with IT to enhance the eQMS across the organization.

You will guide cGMP compliance, oversee CAPA, Change Control, Deviations, and Quality Risk Management, and drive continuous improvement while ensuring inspection readiness and alignment with company