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.

• 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.

• 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.

• 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.

• 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.

• 6 years’ experience with a MS (organic chemistry, biology, analytical or related life science) and progressively responsible QA and analytical related scientific/technical discipline, or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment.
• Hands‑on external quality oversight for clinical phase, extensive QMS experience. Familiarity with QP batch certification (EU Annex 16) and GDP Responsible Person role is an advantage.
• Deep understanding of analytical and QC operations, CMC, regulatory requirements, and best industry practices with proven matrix leadership in managing cross‑functional teams.
• Recognized as a subject matter expert within the organization, with the ability to solve advanced GxP problems and guide others.
• Proficiency with electronic QMS platforms (e.g., Veeva Vault, Master Control or equivalent).
• Start‑up or lean‑team experience; operates without extensive infrastructure.
• Fluent English required;
  German, French and/or Spanish is an advantage.
• Ability to travel up to ~15% to CDMOs.