Director of Clinical QA

QP Group; United States; Remoto; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Formazione

Bachelor of Science in Life Sciences

Descrizione del lavoro

*** Director of Clinical QA Opportunity - remote ***

QP Group is currently partnered with a privately held, clinical-stage biotech pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer & autoimmune disorders. They're looking for someone to collaborate with internal clinical and nonclinical functional groups and external parties including consultants, contract auditors, CRO/Service Provider personnel, and Investigator Sites to promote a high level of quality and consistency across all 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.

Experience Required:

• 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.