Manager – Quality GCP
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Job Location:
Boston, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 crossfunctionally 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.
Required Experience:
Manager
Key Skills
About Company
Pioneering Therapies for Cancer and Beyond – Our drug discovery platform is tailored to promote specific protein ubiquitination and subsequent proteasomal degradation of disease-causing, undruggable proteins, in essence leading to pharmacological protein knockout with high efficiency ... View more
