GCP Quality Manager: Audit & Inspection Readiness

Real Staffing; United States; Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

Real Staffing seeks a Quality Manager II to support the Global Quality Management team, ensuring GCP compliance and internal quality standards across clinical development. The role focuses on auditing, CAPA management, and inspection readiness in a collaborative, cross-functional environment.

You will assist with the maintenance of QMS documentation, travel with auditors as needed, and help track quality metrics and CAPAs across multiple programs.

Qualifications

• Bachelor's degree in Life Sciences or related scientific discipline preferred.
• Foundational knowledge of Good Clinical Practice (ICH E6) and applicable regulations.
• Exposure to clinical trial operations, quality assurance, or monitoring activities preferred.
• Strong organizational and coordination skills.
• Attention to detail and ability to manage multiple priorities.

Responsabilités

• Support the Global Quality Management team in ensuring compliance with GCP, regulatory requirements, and internal quality standards across clinical development activities.
• Coordinate and maintain audit and inspection activities and support GCP audit program.
• Assist with CAPA management, inspection readiness activities, and quality system processes.
• Maintain audit documentation and quality records within electronic quality systems.
• Collaborate with cross-functional teams during audit and quality activities.

Formation

Bachelor's degree in Life Sciences or related scientific discipline

Outils

TrackWise

Veeva

ACE

Microsoft Office

Description du poste

Real Staffing seeks a Quality Manager II to support the Global Quality Management team, ensuring GCP compliance and internal quality standards across clinical development. The role focuses on auditing, CAPA management, and inspection readiness in a collaborative, cross-functional environment.

You will assist with the maintenance of QMS documentation, travel with auditors as needed, and help track quality metrics and CAPAs across multiple programs.