About this opportunity
Cytokinetics, Inc. lists this Director, Clinical Quality Assurance opportunity in south san francisco, California. Review the employer’s description below for duties, qualifications and application requirements.
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.
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Worksite address
south san francisco, CA, 94083, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.