Manager / Sr. Manager – Quality GMP - #47948

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.

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