Job Title: Clinical Quality Assurance
Location: San Francisco, CA (Onsite)
Required Skills
- eQMS and eTMF experience
- Clinical document and CAPA quality review
- internal audit execution and leadership, inspection readiness.
Summary
Consultant needed for Clinical Quality Assurance initiatives and oversight responsibilities for a thriving biopharmaceutical company.
Duties & Responsibilities
- Clinical Quality oversight, including internal audit execution and leadership, inspection readiness, etc.
- Clinical document and CAPA quality review
- Clinical Quality metrics development and tracking and related continuous improvement support
- Other duties, as required
Qualifications & Requirements
- 5 years’ relevant pharma/biotech industry experience including at least 3 years of focused GCP quality experience
- CAPA and Root Cause Analysis experience
- eQMS and eTMF experience
- Excellent written, verbal and interpersonal communication and leadership skills, including cross-functional team collaboration and leadership ability
- Relevant degree