Director, Clinical Quality Assurance
Cytokinetics•South San Francisco, CA
•$222,480 - $259,560•Hybrid
About The Position
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.
Requirements
- 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
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
Benefits
- equity in the form of stock options and/or restricted stock units
- comprehensive health, dental, vision, life and disability insurance coverage
- 401k retirement benefits with employer match
- learning and wellness stipends
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Director
