CRISPR Therapeutics Senior Manager/Associate Director, GCP Quality in Cambridge, Massachusetts
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
This individual will have primary responsibility for supporting the Head of GCLP Quality with GCP activities at CRISPR, its CROs, and Investigator Sites. The successful hire will ensure high quality execution of clinical trials from first in human through commercial marketing authorization. This person will interact with internal and external stakeholders and be the Quality Assurance representative to clinical teams. This individual will be hands on with internal and external partners. This is a high visibility position with great impact potential.
• Assist in the development, implementation, and maintenance of GCP Quality Systems and SOPs• Train and mentor staff on global GCP regulations and Guidelines• Actively participate in Clinical Operations meetings and provide timely updates to management• Conduct CRO and Investigator site monitoring; support inspection readiness initiatives• Identify Quality and Compliance related issues and implement practical solutions while ensuring timelines are maintained• Conduct QA oversight and audit of eTMFs• Lead/oversee consultant mediated audits; Develop, recommend, and follow up on corrective actions• Lead and manage GCP Inspections on behalf of CRISPR• Periodically report the state of GCP Quality and Compliance of clinical trials to CRISPR senior management• The candidate must be able to problem solve, communicate effectively, and trouble-shoot creatively
• BS in Biological Sciences or related fields• Senior Manager: A minimum 5 years of relevant industry experience in Sponsor companies, CROs, or GCP consulting. Associate Director: A minimum of 7-10 years of relevant industry experience in Sponsor companies, CROs, or GCP Consulting.• Direct experience in managing Health Authority GCP Inspections• Excellent communication, writing and presentation skills• Demonstrated ability to work independently and in a team environment and seek resources as necessary• Ability to assess complex issues, break down into components and propose viable solutions• Demonstrated ability to lead and organize team meetings• Ability to foster effective relationships with vendors, investigators and colleagues• Excellent knowledge of Global GCP regulations and industry standards• Proficiency in study monitoring activities• Knowledge of the infrastructure and operational characteristics of CROs and centralized services• Demonstrated effective time management skills• Must be willing to travel domestically and internationally up to 15-20%
• MS or advanced degree in Biological Sciences or related fields• Five or more years in a QA GCP regulated role• Global trial management experience• Prior Clinical Monitoring and/or CRO experience• Knowledge of First in Human trial management• Experience with Cellular Therapy trial management
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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