Clinical and preclinical stages of development for genomic medicines for serious diseases (gene & cell therapy & genome editing)
Greater San Francisco area
Senior Director, R&D & Clinical Quality Assurance
Full-time, direct hire
This individual will be responsible for providing leadership, strategic vision and efficient execution in managing compliance related to GCPs, GLPs, GPVPs and other related activities to deliver clinical goals.
The Sr. Director will establish and oversee R&D, Preclinical, Clinical and Pharmacovigilance QA activities associated with cell and gene therapy products.
- Someone with demonstrated in-depth experience of establishing and managing R&D and CQA functions in compliance with GCP, GLP, and GPVP regulations
- MS or equivalent in a relevant, scientific field with significant experience in an FDA-regulated environment.
- Minimum 15 years of experience in the pharmaceutical industry with a GCP focus, ideally covering all clinical phases through commercial drug product, with at least 5 years in a GCP quality/compliance role.
- Broad knowledge of clinical processes and procedures, electronic documentation systems, and GCP, GLP and GPVP regulations and guidance with demonstrated effectiveness in maintaining CQA control processes for compliance with regulations.
- Experience conducting quality audits of CROs and Investigational sites.
- In-depth knowledge of FDA and ICH regulatory requirements. Experience with EMA and WHO regulations a plus.
- This position requires up to 25% travel
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.