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.

• 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, 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

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