Senior Director / Director – GCP Quality

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

Job summary

Monte Rosa Therapeutics seeks a Senior Director/Director Quality GCP to provide strategic oversight of phase-appropriate GCP and GCLP activities, including vendor and investigator site oversight, for active programs. This role requires 75% on-site presence in Boston/Basel and collaboration across cross-functional teams.

The candidate will author SOPs, develop risk-based GCP programs, and lead inspection readiness while coordinating with internal and external partners in a fast-paced startup

Qualifications

• BS degree in a life science with quality/technical experience
• Minimum of 16 years in pharma/biopharma with development and exposure to commercial operations
• Knowledge of clinical and commercial systems supporting GCP compliance (FDA/EMA/ICH/MHRA); GLP experience a plus
• Solution-minded, flexible to challenges and able to balance priorities in a fast-paced startup environment
• Understanding of drug development and program management preferred

Responsibilities

• Act as primary GCP Quality contact for vendors and investigator sites and quality events (e.g., major breach assessments, CAPAs)
• Author key GCP quality SOPs and reviewer for other quality 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
• Qualification of vendors and compliant vendor management with regular audits; conduct GCP audits as needed
• Provide QA GCP review for regulatory submissions
• Lead inspection readiness activities for regulatory inspections
• Interface with internal departments and external vendors on technical/quality topics

Skills

GCP Quality

Leadership

Quality systems

Education

BS in Chemistry/Pharmacy/Biology

Job description

Senior Director / Director – GCP Quality

Monte Rosa Therapeutics is seeking a Senior Director / 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.

Monte Rosa Therapeutics rational approach in targeting disease-causing proteins for degradation will deliver pioneering therapies for cancer and other diseases. Delivering this new generation of treatments to the patients requires a conceptual change. Monte Rosa recognizes this urgent need and is missioned to develop innovative protein degraders as a solution. Combining deep knowledge, insight and leading-edge science, our integrated engine is built for that purpose