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 supportextneral 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; 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 regulationsQuality 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 itemsRegulatory & 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, analytic or related life science); and includes progressively more 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