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.
