Associate Director, Clinical Quality Assurance
$206,150–$227,850 year
Remote · United States or US
EXPIREDUnited States or USRemoteFull Time$206,150–$227,850 yearMid LevelBachelors DegreeLarge
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Large
Job Summary
Cytokinetics seeks an Associate Director, Clinical Quality Assurance to oversee compliance with GCP and quality standards across global clinical studies, advising clinical operations and ensuring inspection readiness. The ideal candidate will have extensive experience in quality/regulatory compliance within the pharma/biotech sector.
Required Qualifications
- B.S degree in life sciences
- 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries
- Current and strong working knowledge of U.S. and European regulations and guidance including ICH-GCP
- Experience in hosting or supporting clinical trial or Drug Safety-related regulatory inspections
- Ability to lead cross-functional teams and independently prioritize work
Desired Qualifications
- Experience with electronic Quality Management Systems and Trial Master File
- Auditor certifications
Additional Requirements
- Up to 10% travel may be required
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