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; escalate 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 training, as appropriate.
• Provide risk-based GMP impact assessments aligned with international regulations

Quality Assurance and Analytical GMP responsibilities

• Review MBRs/EBRs, analytical methods, validation protocols/reports, specifications, release data packages and stability protocols/reports
• Support clinical batch release/disposition in collaboration with CMC and Supply Chain
• Manage / Lead internal and external quality events (e.g. change controls, deviations, troubleshooting, investigations, CAPAs) and ensure timely closure; proactively flag overdue items

Regulatory & Compliance

• Provide Quality input to CMC sections of regulatory submissions
• Support inspection readiness activities; assist in preparation and remediation of audit responses.
• Maintain GDP compliance for clinical trial material distribution; support cold chain oversight.