Senior Director, GCP Quality & Compliance Leader

Monte Rosa Therapeutics; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Monte Rosa Therapeutics seeks a Senior Director/Director Quality GCP to provide strategic oversight of phase-appropriate GCP and GCLP activities, including vendor and investigator site oversight, for active programs. This role requires 75% on-site presence in Boston/Basel and collaboration across cross-functional teams.

The candidate will author SOPs, develop risk-based GCP programs, and lead inspection readiness while coordinating with internal and external partners in a fast-paced startup

Qualifications

• BS degree in a life science with quality/technical experience
• Minimum of 16 years in pharma/biopharma with development and exposure to commercial operations
• Knowledge of clinical and commercial systems supporting GCP compliance (FDA/EMA/ICH/MHRA); GLP experience a plus
• Solution-minded, flexible to challenges and able to balance priorities in a fast-paced startup environment
• Understanding of drug development and program management preferred

Responsibilities

• Act as primary GCP Quality contact for vendors and investigator sites and quality events (e.g., major breach assessments, CAPAs)
• Author key GCP quality SOPs and reviewer for other quality procedures
• Develop a risk-based GCP compliance program
• Support initiation, review, and closure of quality events and CAPA/Change/Effectiveness plans
• Develop and provide GCP and other GxP training as applicable
• Qualification of vendors and compliant vendor management with regular audits; conduct GCP audits as needed
• Provide QA GCP review for regulatory submissions
• Lead inspection readiness activities for regulatory inspections
• Interface with internal departments and external vendors on technical/quality topics

Skills

GCP Quality

Leadership

Quality systems

Education

BS in Chemistry/Pharmacy/Biology

Job description

Monte Rosa Therapeutics seeks a Senior Director/Director Quality GCP to provide strategic oversight of phase-appropriate GCP and GCLP activities, including vendor and investigator site oversight, for active programs. This role requires 75% on-site presence in Boston/Basel and collaboration across cross-functional teams.

The candidate will author SOPs, develop risk-based GCP programs, and lead inspection readiness while coordinating with internal and external partners in a fast-paced startup