Job Description
The Manager, GMP Quality is responsible for the oversight and day-to-day quality interface with CDMO producing DS & DP for MRTx's ongoing clinical programs.. This includes supporting the review of MBRs/EBRs, analytical methods, validation protocols/reports, specifications, release data packages and stability protocols/report. This role will also supportextneral audits , inspection readiness and regulatory authority inspections.
CDMO & Vendor Quality Oversight
- Primary GMP/GDP Quality contact for identified vendors (DS & DP) supporting clinical programs; day-to-day quality interface.
- Support new vendor qualification, audits and Quality Technical Agreements (QTAs) management.
- Monitor vendor compliance; elevate risks to Sr. Leadership in a timely, structured manner.
Documentation & Quality Systems
- Author and maintain GMP/GDP SOPs with a phase-appropriate approach; develop and provide cGMP and other GxP traini...