Remote-Eligible Senior Clinical QA Director

Dren Bio, Inc.; San Carlos (CA); Hybrid; USD 190,000 - 225,000; Full time

Benefits offered by this job

Competitive cash compensation

Equity incentive awards

Employer-sponsored benefits

Job summary

Dren Bio, Inc. is seeking a Director of CQA in San Carlos, CA (remote candidates may be considered) to lead quality assurance across clinical and nonclinical programs.

The role collaborates with internal teams and external auditors to ensure GxP compliance and readiness for regulatory inspections. The candidate will manage audits, CAPA programs, and quality systems, while maintaining regulatory knowledge and strong cross-functional relationships.

Qualifications

• Bachelor of Science (B.S.) degree in a scientific, life science, or medical/technical discipline.
• 10+ years in the pharmaceutical industry with 8+ years in a GCP/CQA quality role.
• 5+ years leading or independently performing CQA audits and CAPA management.

Responsibilities

• Provide leadership for Inspection Readiness activities and Regulatory Authority Inspections.
• Maintain up-to-date knowledge of ICH GCP and applicable GxP regulations and integrate into processes.
• Develop and maintain CQA documents and procedures compliant with ICH GCP.

Skills

Leadership

Quality Systems

Audit Management

GxP Compliance

Regulatory Knowledge

Communication

Cross-functional collaboration

MS Office

Education

B.S. degree in science

Job description

Dren Bio, Inc. is seeking a Director of CQA in San Carlos, CA (remote candidates may be considered) to lead quality assurance across clinical and nonclinical programs.

The role collaborates with internal teams and external auditors to ensure GxP compliance and readiness for regulatory inspections. The candidate will manage audits, CAPA programs, and quality systems, while maintaining regulatory knowledge and strong cross-functional relationships.