Sr. Director Clinical Quality Assurance
Reporting to Head of Quality, this individual will have primary responsibility for QA oversight of GCP activities at 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.
Here's What You'll Do:
- Lead development, implementation, and maintenance of GCP Quality Systems and SOPs through Clinical Study Startup, Maintenance and Close out.
- Train and mentor staff on global GCP regulations and guidance
- 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 manage GCP Inspections
- Periodically report the state of GCP Quality and compliance of clinical trials to Vedanta QA and 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
- 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
- Must be willing to travel 15-20%
Sthree US is acting as an Employment Business in relation to this vacancy.