Inspection Readiness Manager - Ehub Global Inc

Title/Role: Inspection Readiness Manager

Location: Seaport, Boston, MA (HYBRID)

Duration: 6+ months with chance to extend

General position summary: This role is responsible for managing real time inspection readiness activities supporting GMP and GDP quality.

Key Responsibilities:

• Real-time Inspection Readiness
• Develop, manage and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities
• Work directly with CMOs and the Manufacturing Center on inspection readiness activities, including identification of potential inspection risks
• Provide additional support for CMO inspection readiness plans and support management of CMO inspections and responses

Minimum qualifications:

• Master’s degree and 3 – 4 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 5+ years of relevant work experience, or relevant comparable background
• Proficient at creating tools and processes for efficient execution
• Proficient in project management and utilization of PM tools
• GMP/GDP regulations and application to Manufacturing and Testing risk management principles
• Root Cause Analysis tools/methodology and CAPA