Director – Quality GCP

Overview

Monte Rosa Therapeutics is seeking a 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.

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