Director – Quality GCP

Overview

Monte Rosa Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs through participation on in-house and external cross-functional teams. This role requires an 75% on-site presence. You will work closely with industry leaders in Boston and Basel . Join a diverse, collaborative, and dynamic team that values innovation, teamwork, and a people-centric culture!

Responsibilities

• Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs as well as other GCP quality events (e.g., potential serious breach assessments, CAPAs)
• Author key GCP quality SOPs and key reviewer for other quality (GxP) procedures.
• Develop a risk-based GCP compliance program.
• Support teams in the initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans.
• Develop and provide GCP and other GxP training (as applicable).
• Ensure appropriate qualification of vendors and ensure compliant vendor management and regular assessment / audits. May conduct GCP audits (vendors and sites).
• Ensure audit observations are communicated, tracked and remediated.
• Provide QA GCP review and feedback on regulatory submissions.
• Lead and participate in inspection readiness activities for regulatory inspections – both internally and at clinical sites.
• Interface with internal departments and external vendors on a variety of technical / quality subjects.

Qualifications

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