With over 15 products in their pipeline, why not investigate working with the best Gene Therapy organization in the country? This Biotech company is looking for a Sr. Manager, GCP R&D Quality to assist the Director in overseeing all GxP functions. With you exquisite GCP background, apply in!
- providing GCP/GVP/GCLP/GLP (GxP) QA oversight for research & development (R&D) activities
- This is an opportunity to help develop the GxP QA function and ensure high quality execution of clinical trials from first in human through commercial marketing authorization.
- Lead and support R&D QA GxP Inspection readiness efforts and activities during preparation, conduct, and follow-up for Regulatory Agency inspections
- Provide project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks
- No Traveling
- Reporting into Director, R&D QA
What they need:
- Five (5) or more years of Quality Assurance experience in a GCP-focused role, or equivalent work experience OR 1-2 years in GCP QA
- Inspection readiness
- Basic QA functions