Manager/ Director of Quality Assurance
Crystal PharmatechCalifornia, United States
Posted March 13, 2025
Full Time
About the Company
Crystal Bio Solutions, a leading biologics analytical organization with operations in the San Francisco Bay Area and New Jersey.
Job Description
Reporting directly to the CEO, the Director of Quality Assurance (QA) will be responsible for the development, management, and continuous improvement of quality systems ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for our bioanalytical GLP lab in Pleasanton, California.
Requirements
- 10+ years of relevant regulatory affairs experience in the bioanalytical CRO or biotechnology/pharmaceutical industry, or a combination of education and experience.
- Bachelor’s degree in biological, chemical, or physical sciences (required); advanced degrees (e.g., Master’s, Ph.D.) preferred.
- Proven ability to provide regulatory leadership and guidance in cross-functional and matrixed environments.
- Strategic thinker with strong planning skills and the ability to propose innovative solutions to regulatory challenges.
Benefits
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Parental leave
- Wellness resources
