Senior Manager, GCP Quality

CRISPR Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 04/02/2021
  • Website: crisprtx.com
  • Company Address: 610 Main Street, Cambridge, MA, 02139

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene-editing company focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

Job Description

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.

Job Summary
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 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.

Responsibilities

• 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

Minimum Qualifications

• BS in Biological Sciences or related fields
• Minimum 5 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%
Preferred Qualifications
• 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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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.