Note: The job is a remote job and is open to candidates in USA. QP Group is partnering with a privately held, clinical-stage biotech developing antibody therapeutics for cancer and autoimmune disorders. The Director of Clinical QA will support inspection readiness, maintain clinical quality processes, execute GCP audits, and collaborate with internal and external teams to promote quality and regulatory compliance across development programs.

Responsibilities

• Provide leadership and support for Inspection Readiness activities and initiatives, and for the preparation, conduct, and response periods of Regulatory Authority Inspections
• Maintain expert up-to-date knowledge on applicable regulations that govern the conduct of clinical trials, ICH GCP guidelines and other GxP regulations and industry guidance and ensure the information is integrated into Quality and Clinical processes
• Support the development and maintenance of CQA controlled documents and procedures that comply with ICH GCP standards and applicable regulations
• Create and execute annual audit plan to ensure GCP compliance and adherence to study protocols by vendors, Investigator sites, study databases, and internal clinical team
• Author and/or review procedures to support the Quality Management System, with an emphasis on clinical quality processes, clinical operations and clinical development functions
• Collaborate with clinical functional groups (e.g., Clinical Operations, Data Management, etc.) to provide GCP and regulatory compliance support at the study execution level. This includes Clinical Study Execution Team (CSET) membership and participation

Skills

• Minimum of a Bachelor of Science (B.S.) degree in a scientific, life science, or medical/technical discipline
• Minimum of 10 years' experience within the pharmaceutical industry with at least 8 years of experience in a GCP or CQA quality role, with increasing levels of responsibility
• Minimum of 5 years' experience in leading or independently performing CQA audits (Vendor qualification/routine/for-cause, Investigator Site, Gap Assessment, TMF, CSR, etc.), and audit CAPA management

Benefits

• Remote work

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