GMP Quality Lead: CDMO Oversight & Compliance

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

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.