Manager / Sr. Manager – Quality GMP

Monte Rosa Therapeutics Inc.; Basel; Vor Ort; CHF 100.000 - 130.000; Vollzeit

Zusammenfassung

Monte Rosa Therapeutics Inc. in Basel is seeking a Manager for GMP Quality who will oversee quality interface with CDMOs involved in ongoing clinical programs. This role requires strong experience in quality oversight, documentation, and regulatory compliance.

The ideal candidate has a Master’s degree and at least 6 years of experience in the pharmaceutical industry, complemented by a deep understanding of QMS, GMP regulations, and analytical processes. Knowledge of electronic QMS platforms like Veeva Vault is advantageous.

Qualifikationen

• 6 years of experience in QA and analytical roles in a GMP environment.
• Hands-on experience with QMS, especially in clinical phases.
• Subject matter expert in GxP-related challenges.

Aufgaben

• Oversee day-to-day quality interface with vendors for clinical programs.
• Review and maintain GMP/GDP documentation and SOPs.
• Support regulatory submissions and inspection readiness activities.

Kenntnisse

Quality oversight

GMP knowledge

Analytical methods

Regulatory compliance

Risk management

Team leadership

QMS experience

Ausbildung

Master's degree in life sciences

Tools

Veeva Vault

MasterControl

Jobbeschreibung

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 support external 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; elevate risks to Senior 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, analytical or related life science) and progressively 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.