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 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.
Qualifications
* 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, MasterControl 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.
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