Director, Clinical Quality Assurance

Cytokinetics, Inc.; South San Francisco (CA); Hybrid; USD 222,000 - 260,000; Full time

Benefits offered by this job

Stock options/RSUs

Comprehensive health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401k with employer match

Learning & wellness stipends

Paid time off

Job summary

Cytokinetics, Inc. in South San Francisco, CA is seeking a Director, Clinical Quality Assurance to lead the Clinical QA department.

The role oversees quality programs, ensures regulatory compliance in international environments, and guides the CQA team on policies, procedures, and quality system elements. The position requires a life sciences degree with 12+ years in GCP, strong regulatory knowledge (US CFR, EU regulations, ICH-GCP), staff development, and risk-based thinking.

Qualifications

• Bachelor’s degree in life sciences with 12+ years of experience in a GCP-related discipline.
• Strong working knowledge of US CFR and European regulations, and ICH-GCP guidance.
• Experience managing and developing staff.
• Ability to communicate vision and prioritize based on risk.

Responsibilities

• Develop the GCP QA organizational strategy and lead Clinical QA staff.
• Develop and implement GCP strategy, metrics, QA limits, and analytics.
• Streamline QA processes and implement improvements with cross-functional teams.
• Lead inspection readiness activities for internal and external entities.
• Co-host GCP, GLP, and GVP inspections.
• Manage a risk-based audit program and staff.
• Support internal audits of GCP/GVP processes and vendor/site audits.
• Ensure QA participation on study teams and remediation of gaps.
• Review SOPs, audit reports, and quality event records.
• Create and manage department budget.

Skills

GCP knowledge

Regulatory interpretation

Staff management

Risk-based thinking

Education

Bachelor's degree in life sciences

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

The Director, Clinical Quality Assurance (CQA) will be responsible for the overall operation of Cytokinetics Clinical QA department. They will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in an international regulatory environment. They will lead the CQA group responsible for quality plans, policies, procedures, and quality system elements in support of clinical programs. The Director, CQA will provide guidance on CQA related matters.

Responsibilities

• Develop the GCP QA organizational strategy, manage and develop Clinical QA staff to support and enhance quality improvement initiatives for development programs
• Develop and implement overall GCP strategy, performance metrics, quality tolerance limits, and analytics reports
• Proactively streamline and strengthen clinical QA processes across the organization and implement improvements in collaboration with cross-functional teams
• Lead and ensure inspection readiness activities for internal and external entities
• Lead and co-host GCP, GLP, GVP inspections
• Lead and manage a risk-based audit program
• Manage and support internal audits of GCP and GVP processes, and quality audits of clinical vendors and investigator sites
• Ensure CQA participation on study teams to provide oversight and guidance
• Identify compliance gaps and provide remediation recommendations for continuous improvement
• Review and approve SOPs, audit reports, quality event records as required
• Create, maintain, and adhere to department operating budget

Qualifications

• Bachelor's degree in life sciences with 12+ years experience in a GCP related discipline
• Current and strong working knowledge, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations
• Experience managing and developing staff
• Able to develop innovative solutions to issues and apply critical thinking to problem solving
• Able to organize and prioritize projects and CQA activities based on risk
• Able to effectively communicate vision and expectations to the teams

Contract & Work Location

Hybrid (as indicated by #LI-HYBRID). Up to 10% travel may be required.

Pay Range

The expected salary range for this position based on the primary location of South San Francisco, CA is $222,480 - $259,560.

Benefits

• equity in the form of stock options and/or restricted stock units
• comprehensive health insurance coverage
• dental insurance coverage
• vision insurance coverage
• life insurance coverage
• disability insurance coverage
• 401k retirement benefits with employer match
• learning and wellness stipends
• paid time off

Company Culture & Diversity

Our employees come from different backgrounds, and we celebrate those differences.

We champion integrity, ethics, doing the right thing, and being our best selves.

Cytokinetics is an Equal Opportunity Employer.