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Manager / Sr. Manager – Quality GMP

Monte Rosa Therapeutics, Inc
Basel, BS

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%
CHF 115’000 - CHF 140’000 pro Jahr
vor 1 Tag

Qualifikationen

Französisch
Spanisch
Englisch
Klinische Erfahrung
Deutsch

Vollständige Stellenbeschreibung

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

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