Manager Sr. Manager – Quality GMP

The Manager GMP Quality is responsible for the oversight and day-to-day quality interface with CDMO producing DS & DP for MRTxs 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.

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