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 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, 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
