Senior Director – Quality GCP

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

Job summary

Monte Rosa Therapeutics, Inc. seeks a Senior Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities.

This role includes GCP quality oversight of ongoing activities supporting pre-clinical and clinical programs, with 75% on-site presence in Boston and collaboration with Basel teams. Qualified candidates bring 16+ years in pharma/biopharma, strong GCP/regulatory knowledge, and proven leadership in fast-paced, matrixed environments.

Qualifications

• BS Degree in Chemistry, Pharmacy, Biology or related life science, or a BS with relevant Quality/Technical experience.
• Minimum of 16 years in pharmaceutical/biopharmaceutical industry with development and exposure to commercial ops.
• Knowledge of clinical and commercial systems supporting GCP compliance with US/global regs (FDA/EMA/ICH/MHRA). GLP experience a plus.
• Solution-minded, flexible to emerging challenges and able to balance competing priorities.
• Hands-on leader with drug development and program management understanding preferred.

Responsibilities

• Primary GCP Quality contact for identified vendors and investigator sites and related quality events.
• Author key GCP quality SOPs and review other quality (GxP) 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.
• Ensure vendor qualification and compliant vendor management with audits.
• Communicate, track and remediate audit observations.
• Provide QA GCP review on regulatory submissions.
• Lead inspection readiness activities for regulatory inspections internally and at sites.
• Interface with internal departments and external vendors on technical/quality topics.

Skills

GCP knowledge

Regulatory compliance

Cross-functional collaboration

Leadership

Education

BS degree in Life Sciences

Job description

Overview

Monte Rosa Therapeutics is seeking a Senior 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

• BS Degree in Chemistry, Pharmacy, Biology or a related life science, or a combination of a BS Degree with relevant Quality and Technical experience.
• Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations.
• Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience a plus.
• Able to provide solution-minded approach and flexibility to emerging challenges.
• Able to appropriately balance priorities plus multi-task against competing priorities.
• Proven experience with the desire, and ability to work in a fast-paced, matrixed, start-up environment.
• Hands-on leader, able to provide solution-minded approach and flexibility to emerging challenges
• Understanding of drug development and program management preferred.