Manager – Quality GCP

Monte Rosa Therapeutics

Human Health and Social Work

Boston, MA - USA

Manager / Team Leader

Experteer Overview

In this role you will drive GCP quality oversight for phase-appropriate programs, collaborating across Clinical Operations, Regulatory Affairs and external partners. You will manage quality events, RBQM activities, vendor oversight, and audits to ensure compliant, inspection-ready processes. You will author and maintain GCP documents, train teams, and support regulatory submissions and inspections. This position offers impact across pre-clinical to clinical programs, shaping quality strategies and cross-functional quality culture.

Responsibilities

Serve as main GCP Quality contact for vendors and investigator sites
Identify and manage GCP quality events, deviations, breaches, CAPAs, changes, and effectiveness checks
Author and maintain GCP SOPs and templates; review other GxP procedures
Support RBQM activities including risk assessments and mitigation plans
Support vendor qualification, ongoing oversight, and audits; may conduct GCP audits
Track and remediate audit observations to ensure timely resolution
Provide GCP and GxP training to internal teams and external partners
Perform QA GCP reviews of regulatory documents and submissions for accuracy
Support inspection readiness and regulatory inspections, including materials and responses
Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and other teams on quality and compliance topics

Key requirements

BS in Chemistry, Pharmacy, Biology or related life science (or combination with relevant Quality/Technical experience)
Minimum 8 years of pharmaceutical/biopharmaceutical experience, with development exposure and some commercial operations experience
Knowledge of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA); GLP experience a plus
Solution-minded approach and flexibility to evolving challenges

solution-minded flexibility cross-functional collaboration GCP/GxP knowledge RBQM and risk assessment vendor qualification and oversight/audits

Description

In this role you will drive GCP quality oversight for phase-appropriate programs, collaborating across Clinical Operations, Regulatory Affai…

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