Manager – GCP
Monte Rosa Therapeutics
June 29, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Responsibilities:
- Serve as a primary GCP Quality contact for assigned vendors and investigator sites supporting clinical programs.
- Support identification, assessment, documentation, and management of GCP quality events (deviations, potential serious breaches, CAPAs, change actions, 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.
- 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 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 for accuracy and compliance, as applicable.
- Participate in inspection readiness and regulatory inspections, including preparation of materials and responses.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and other internal teams on quality and compliance.
Qualifications:
- BS in Chemistry, Pharmacy, Biology, or related life science; or BS plus relevant Quality and Technical experience.
- Minimum 8 years in pharmaceutical/biopharmaceutical industry 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 a plus.
- Solution-minded approach and flexibility to emerging challenges.
Application Instructions:
- Forward a resume and cover letter in once document via the career portal: https://www.monterosatx.com/careers/
- Serve as a primary GCP Quality contact for assigned vendors and investigator sites supporting clinical programs.
- Support identification, assessment, documentation, and management of GCP quality events (deviations, potential serious breaches, CAPAs, change actions, 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.
- 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 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 for accuracy and compliance, as applicable.
- Participate in inspection readiness and regulatory inspections, including preparation of materials and responses.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and other internal teams on quality and compliance.
Qualifications:
- BS in Chemistry, Pharmacy, Biology, or related life science; or BS plus relevant Quality and Technical experience.
- Minimum 8 years in pharmaceutical/biopharmaceutical industry 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 a plus.
- Solution-minded approach and flexibility to emerging challenges.
Application Instructions:
- Forward a resume and cover letter in once document via the career portal: https://www.monterosatx.com/careers/