Senior Director, Quality GCP — Strategic QA Leader

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

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.