Manager / Sr. Manager – Quality GMP

Overview

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 support external audits, inspection readiness and regulatory authority inspections.

Responsibilities

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 Senior Leadership in a timely, structured manner.

Documentation & Quality Systems

• Author and maintain GMP/GDP SOPs with a phase-appropriate approa...