5 days ago
Greater New York City Biotech aggressively searching for a senior level individual with Gene Therapy experience to build out their Quality Assurance function.
Reporting to the Head of Development, the Director OR Senior Director of Quality Assurance will be the coordinator of all internal and external parties involved in the progression of the current gene therapy candidates in the pipeline. This individual's paramount responsibility will be ensuring the quality and performance of each candidate is compliant with all aspects of GxP.
- Develop the Quality function, including Corporate Quality, GCP, GLP and GMP compliance systems, SOPs and staff, to support growing portfolio of clinical development programs
- Serve as the lead and expert in the development, implementation, and training of cGMP compliant quality systems (i.e., document control, change control, investigations, deviations, CAPA, and product/customer complaints)
- Work cross-functionally with Process Development, Preclinical, Technology Development, QC, Regulatory, and Program Management to implement development strategies and ensure quality is embedded in all aspects of ongoing and planned clinical, nonclinical, and development GXP activities
- Ensure that manufactured gene therapy products are of high quality, safe for human use, and are in compliance with cGMP and international regulations
- Collaborate with regulatory to support IND/NDA/MAA filings/amendments on CMC sections
- Thorough experience in the biotech/biopharmaceutical manufacturing industry with prior experience in QA focused on gene therapy
- Working knowledge of cGMPs
- Able to manage CMO/CRO relationships and activities
- BA/BS/University degree in Life/Health Sciences required; advanced degree preferred
- Excellent verbal and written communication skills with the ability to thrive in a fast-paced environment
This unique position does not come around often! Working with this collaborative, hard-wired team makes the environment competition for every other biotech in the country! If this is the position for you please apply and contact me directly!