Monte Rosa Therapeutics · 1 day ago
Director – Quality GCP
Boston, MA
Full-time
Onsite
Director/Executive
16+ years expMonte Rosa Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities. This role involves working closely with industry leaders and ensuring compliance with GCP standards while managing vendor and investigator site relationships.
BiotechnologyMedicalTherapeutics
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
Qualification
Required
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
Preferred
Understanding of drug development and program management preferred
Company
Monte Rosa Therapeutics
Monte Rosa Therapeutics is a biotechnology company that develops cancer therapeutics that modulate protein degradation pathways.
51-200 employees
H1B Sponsorship
Monte Rosa Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2022 (4)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$648.5MKey Investors
Avoro Capital AdvisorsAisling Capital
2026-01-08Post Ipo Equity· $300M
2024-05-15Post Ipo Equity· $100M
2023-10-26Post Ipo Equity· $25M
Leadership Team
S
Sharon Townson
Chief Scientific Officer
Recent News
2026-01-09
BioWorld Financial Watch
2026-01-09
2026-01-08
Company data provided by crunchbase