Director – Quality GCP

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

Job summary

Monte Rosa Therapeutics, Inc. is seeking a Senior Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, ensuring GCP quality across clinical programs with 75% on-site presence in Boston and Basel.

The role interfaces with cross-functional teams to drive regulatory readiness and continuous quality improvement. You will lead development of risk-based GCP programs, author SOPs, manage vendor qualification, audits, and CAPAs, and support regulatory

Qualifications

• BS degree in Chemistry, Pharmacy, Biology or related life science, or combination with relevant Quality/Technical experience.
• Minimum of 16 years of experience in pharmaceutical/biopharmaceutical industry with development experience and exposure to commercial operations.
• Knowledge/experience of clinical and commercial systems supporting GCP compliance with US/global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience a plus.
• Ability to provide solution-minded approach and flexibility to emerging challenges.
• Ability to balance priorities and multi-task in a fast-paced environment.
• Proven experience in a matrixed start-up setting and hands-on leadership.
• Understanding of drug development and program management preferred.

Responsibilities

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

Skills

Quality GCP

Vendor management

Leadership

Regulatory compliance

Inspection readiness

Cross-functional collaboration

Risk-based thinking

Education

BS Degree in Chemistry, Pharmacy, Biology or related life science

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.