At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.
We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseases
Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.
Reporting to Director GCLP Quality, this individual will have primary responsibility for QA oversight of 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 manage cross functional relationships 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.
Lead development, implementation, and maintenance of GCP Quality Systems and SOPs
Train and mentor staff on global GCP regulations and guidances
Conduct CRO and Investigator site monitoring, and inspection readiness
Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
QA oversight and auditing of eTMFs
Lead and/or 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
Minimum 6 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
Ten 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 hematology and/or transplant
Experience with cellular therapy trial management
Employer will assist with relocation costs.
About CRISPR Therapeutics
We are building a world-class research and development center in Cambridge, Massachusetts with outstanding people who want to make a difference. We’re moving at a rapid pace, and every day presents new excitements and challenges. We rely on each other to tackle these challenges fearlessly, to take measurable steps towards achieving our mission and to have fun.