Job Title: Clinical Quality Assurance
Location: San Francisco, CA
Duration: 12 months
Job Description
Consultant needed for Clinical Quality Assurance initiatives and oversight responsibilities for a thriving biopharmaceutical company. Responsibilities include clinical quality oversight, internal audit execution and leadership, inspection readiness, clinical document and CAPA quality review, clinical quality metrics development and tracking, and related continuous improvement support.
Education & Experience
- Bachelor's or Master's degree
- Minimum of 5 years of relevant pharma/biotech industry experience including at least 3 years of focused GCP quality experience
Skills
- eQMS and eTMF experience
- Clinical document and CAPA quality review
- Internal audit execution and leadership, inspection readiness
- CAPA and Root Cause Analysis experience
- Excellent written, verbal and interpersonal communication and leadership skills, including cross-functional team collaboration and leadership ability