Director, Clinical QA & Inspection Readiness

BioSpace; San Carlos (CA); On-site; USD 190,000 - 225,000; Full time

Benefits offered by this job

Equity incentives

Total rewards program

Job summary

Dren Bio in San Carlos, CA, seeks a Director of CQA to lead audit readiness and ensure GCP compliance across clinical development programs. The role involves managing domestic and international audits, CAPA processes, and maintaining the company’s quality systems in a fast-paced biopharma setting.

The candidate will collaborate with Clinical Operations, Data Management, and external partners, ensuring adherence to ICH GCP standards and regulatory requirements while driving continuous improvement

Qualifications

• Bachelor's degree in a scientific, life science, or medical/technical field.
• 10+ years in the pharmaceutical industry with at least 8 years in a GCP or CQA quality role, with increasing levels of responsibility.
• 5+ years leading or independently performing CQA audits (Vendor qualification/routine/for-cause, Investigator Site, Gap Assessment, TMF, CSR).

Responsibilities

• Lead and support inspection readiness activities and regulatory authority inspections.
• Maintain up-to-date knowledge of regulations governing clinical trials and GxP.
• Develop and maintain CQA controlled documents and procedures.
• Create and execute annual audit plans to ensure GCP compliance across vendors and sites.
• Author/reviewQuality Management System procedures emphasizing clinical quality processes.
• Collaborate with clinical teams to provide GCP and regulatory compliance support at the study level.
• Review study documents for regulatory compliance and risk at study and company levels.
• Conduct risk assessments for critical activities impacting subject safety and data quality.
• Lead audits and investigations, report findings, and drive CAPA implementations.

Skills

Audit management

Regulatory compliance

ICH GCP knowledge

CQA audits

Quality systems

Education

Bachelor of Science in a scientific, life science, or medical/technical discipline

Tools

MS Excel

MS Word

Job description

Dren Bio in San Carlos, CA, seeks a Director of CQA to lead audit readiness and ensure GCP compliance across clinical development programs. The role involves managing domestic and international audits, CAPA processes, and maintaining the company’s quality systems in a fast-paced biopharma setting.

The candidate will collaborate with Clinical Operations, Data Management, and external partners, ensuring adherence to ICH GCP standards and regulatory requirements while driving continuous improvement