Director, Clinical Quality Assurance
Cytokinetics
Summary
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.
Job description
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
- Up to 10% travel may be required
Requirements
- Bachelor's degree in life sciences
- 12+ years experience in a GCP related discipline
- Current and strong working knowledge of US and European regulations and guidance, including ICH-GCP
- Experience managing and developing staff
- Able to develop innovative solutions and apply critical thinking
- Able to organize and prioritize projects based on risk
- Able to effectively communicate vision and expectations
Benefits
- Stock options
- Restricted stock units
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401k retirement benefits
- Employer match
- Learning stipends
- Wellness stipends
- Paid time off
Company overview
Cytokinetics, Incorporated is a late-stage biopharmaceutical company headquartered in South San Francisco, California, specializing in muscle biology research and drug development. Founded in 1997 by leading scientists from Stanford, UCSD, and UCSF, the company focuses on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors for debilitating diseases characterized by impaired or declining muscle function. With over 25 years of scientific expertise, Cytokinetics has built a robust pipeline targeting cardiovascular and neuromuscular conditions including heart failure, hypertrophic cardiomyopathy, and amyotrophic lateral sclerosis (ALS). The company's innovative approach centers on directly targeting the sarcomere, the fundamental unit of muscle contraction, to develop potential treatments that may preserve and extend independence for patients. Cytokinetics operates as a publicly traded company (NASDAQ: CYTK) and has established itself as a leader in muscle biology with more than 115 publications, over 100 clinical trials, and hundreds of issued patents.