Associate Director, Clinical Quality Assurance Auditor
Cytokinetics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $195,300 - $227,850 per year
Job Level
Tech Stack
About the role
- Serve as the CQA audit program process owner
- Principal lead auditor for GCP, GVP, and GLP audits
- Develop, implement, and maintain a risk-based global clinical audit program
- Analyze and manage audit program metrics
- Lead inspection readiness activities for global health authority inspections
- Assist with quality review of key clinical documents
- Design and conduct GCP Training for functional departments
- Provide mentoring and oversight to QA staff
Requirements
- Bachelor'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 United States Code of Federal Regulations and European regulations
- Auditor certification is preferred
- Up to 60% travel may be required
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
GCPGVPGLPrisk-based audit programaudit program metricsinspection readinessquality reviewGCP Training
Soft Skills
mentoringoversight
Certifications
auditor certification