CAPA Manager

Job Summary

Supporting Delivery Units in the CAPA development and implementation process, the fully remote CAPA Manager will oversee the Nonconformance/CAPA process, act as a subject matter expert, and coach Investigation Owners through structured problem-solving methodologies.

Key Responsibilities:

• Act as CAPA Champion and process/system SME for nonconformance and CAPA processes
• Assist Investigation Owners in Root Cause Analysis (RCA) investigations and ensure compliance with process requirements
• Monitor nonconformance and CAPA deliverables, escalating concerns to management as needed

Required Qualifications:

• Bachelor's Degree in Science (BSc) or Arts (BA) with 7-8 years of Pharmaceutical Industry experience
• 3-4 years of GXP experience within clinical research and development and/or quality assurance
• Experience in Quality Control, Compliance, and CAPA processes
• Strong knowledge of FDA/ICH regulations related to clinical development
• Demonstrated project leadership skills and the ability to interface with all levels of the organization