Clinical and preclinical stages of development for genomic medicines for serious diseases (gene & cell therapy & genome editing)
Greater San Francisco area
Manager, R&D & Clinical Quality Assurance
Full-time, direct hire
This individual will be responsible for providing quality oversight for the R&D and clinical programs related to the company's genome editing and AAV gene therapy.
- Minimum of a Bachelor's degree in life science or equivalent .
- Demonstrated in-depth experience of establishing, refining and operating R&D and Clinical Quality Assurance related systems in the Biotechnology industry.
- 5+ experience in a combination of R&D Quality Assurance and Clinical Operations roles.
- 8+ years' experience working in a regulated industry.
- In depth knowledge of FDA, ISO, EMA, GMP, GCP and ICH quality systems and regulatory requirements for clinical programs including cell-based, gene-based and rAAV-based therapies.
- In-depth knowledge of FDA and ICH regulatory requirements. Experience with EMA and WHO regulations a plus.
If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.