GMP Project Manager

Job Summary

Representing as the Single Point of Contact for all raw material test labs, the full-time Raw Material Contract Testing Project Manager (GMP) will lead the resolution of operational issues, track testing status, and manage communication with internal stakeholders in a remote setting.

Key responsibilities

• Lead resolution of operational issues related to contract test laboratories and collaborate with other functions to address quality or technical issues
• Track and communicate raw material sample testing status and delays to internal stakeholders, including obtaining CoA release dates and updating internal trackers
• Approve CTL invoices, manage PO spend for each test lab, and gather operational metrics for business review meetings with CTLs

Required qualifications

• Master's Degree with 3+ years of GMP experience or Bachelor's Degree with 5+ years of GMP experience or Associate's Degree with 7+ years of GMP experience or High School Degree with 10+ years of GMP experience
• Demonstrated knowledge of Good Manufacturing Practices (GMPs) and experience working with contract test laboratories
• Strong analytical skills with proficiency in data analytics tools such as Tableau and Excel
• Experience in managing operational metrics and communication within a matrix environment
• Ability to proactively identify and mitigate risks while maintaining a patient-centric mindset