Director, GCP Quality Assurance
Reporting to Head of 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 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
- 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
- Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands
- Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
- Effective Planning - Embedding discipline and thoroughness in our approaches.
- Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
- Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
- Relationship Building – Builds productive working relationships across a diverse spectrum of people.
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.