Remote Director, Clinical QA & Audit Excellence

QP Group; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

QP Group is seeking a Director of Clinical QA to lead inspection readiness and ensure GCP/CQA compliance across development programs in a remote capacity. The role involves collaboration with clinical and nonclinical teams, consultants, CROs, and investigator sites to uphold quality standards.

Applicants should have a BS in life sciences, at least 10 years in pharma with 8+ in GCP/CQA roles, and a track record of leading audits and CAPA programs. This is a remote senior leadership opportunity.

Qualifications

• BS in a scientific, life sciences, or medical/technical discipline.
• At least 10 years in pharma with 8+ in GCP/CQA quality roles.
• 5+ years leading CQA audits and CAPA management.

Responsibilities

• Provide leadership and support for Inspection Readiness activities and for Regulatory Authority Inspections.
• Maintain up-to-date knowledge on applicable regulations (ICH GCP and GxP) and integrate into Quality and Clinical processes.
• Develop and maintain CQA controlled documents and procedures that comply with ICH GCP and regulations.
• Create and execute annual audit plan to ensure GCP compliance and adherence to study protocols by vendors and sites.
• Author/review procedures to support the Quality Management System, focusing on clinical quality processes and development functions.
• Collaborate with Clinical Operations and Data Management to provide GCP/regulatory support at study execution level.

Education

Bachelor of Science in Life Sciences

Job description

QP Group is seeking a Director of Clinical QA to lead inspection readiness and ensure GCP/CQA compliance across development programs in a remote capacity. The role involves collaboration with clinical and nonclinical teams, consultants, CROs, and investigator sites to uphold quality standards.

Applicants should have a BS in life sciences, at least 10 years in pharma with 8+ in GCP/CQA roles, and a track record of leading audits and CAPA programs. This is a remote senior leadership opportunity.