Manager – Quality GCP

Responsibilities:
- Support phase-appropriate Monte Rosa Quality GCP/GCLP activities and provide GCP quality oversight for ongoing quality activities supporting pre-clinical and clinical programs.
- Serve as primary GCP Quality contact for assigned vendors and investigator sites supporting clinical programs.
- Identify, assess, document, and manage 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), including quality risk assessments and mitigation plans aligned to the quality strategy.
- Support vendor qualification, ongoing vendor oversight, and periodic assessments/audits; may conduct GCP audits of vendors and investigator sites.
- Track, document, and support remediation of audit observations to ensure timely, effective resolution.
- Provide GCP and other GxP training to internal teams and external partners as applicable.
- Perform QA GCP reviews of selected regulatory documents/submissions for accuracy and compliance as applicable.
- Support inspection readiness and regulatory inspections, including preparation of materials and responses.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and other teams on quality and compliance topics.

Qualifications:
- BS in Chemistry, Pharmacy, Biology, or related life science (or BS plus relevant Quality and Technical experience).
- Minimum 8 years’ pharmaceutical/biopharmaceutical experience with development experience and exposure to commercial operations.
- Knowledge/experience with clinical and commercial systems supporting GCP compliance with US/global regulations (FDA, EMA, ICH, MHRA, etc.); GLP experience is a plus.

Skills:
- Solution-minded approach and flexibility to emerging challenges.