Provides strategic GCP and GCLP quality oversight for preclinical and clinical programs. Responsibilities include vendor and investigator site oversight, SOP authorship, risk-based compliance programs, CAPA and quality event management, training, audits, regulatory submission review, inspection readiness, and cross-functional collaboration. Requires extensive pharmaceutical or biopharmaceutical experience, knowledge of global GCP regulations, and leadership in matrixed startup environments.
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.
- 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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