Manager – Quality GCP

Overview

Responsible for support of phase-appropriate Monte Rosa 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.  

Responsibilities

• Serve as a primary GCP Quality contact for assigned vendors and investigator sites supporting clinical programs.• Support the identification, assessment, documentation, and management of GCP quality events, including deviations, potential serious breaches, CAPAs, change actions, and effectiveness checks.• Author and maintain assigned GCP SOPs, work instructions, and templates; review other GxP procedures as needed.• Support risk-based quality management (RBQM) activities, including quality risk assessments and mitigation plans in alignment with established quality strategy.• Support vendor qualification activities, ongoing vendor oversight, and periodic assessments or audits; may conduct GCP audits of vendors and investigator sites.• Track, document, and support remediation of audit observations to ensure timely and effective resolution.• Provide GCP and other GxP training to internal teams and external partners, as applicable.• Perform QA GCP reviews of selected regulatory documents and submissions to ensure accuracy and compliance, as applicable.• Participate in and support inspection readiness activities as well as regulatory inspections, including preparation of materials and responses.• Collaborate cross‑functionally with Clinical Operations, Regulatory Affairs, and other internal teams on quality and compliance topics.

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 8 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.