About the Role
The Director, Clinical Quality Assurance will be responsible for providing quality oversight for the clinical programs related to the company’s ZFP and cDNA Therapeutic® products, including technology platforms for ZFP genome editing, Adeno-associated Virus (AAV) gene therapy and autologous & allogeneic CAR-Tregs. The Director, Clinical Quality Assurance will work closely with Quality Assurance and Clinical Operations to recommend and lead the implementation of quality initiatives to ensure clinical compliance to FDA and international regulations and guidance, including Good Clinical Practices. Will lead the GCP vendor qualification and management efforts. Will be responsible for creating the clinical quality systems necessary to support the client’s Phase III clinical operations goals.
Minimum of a bachelor’s degree in life science or equivalent.
Demonstrated in-depth experience of establishing, refining, and operating Clinical Quality Assurance related systems in the Biotechnology industry.
12+ years’ experience in a combination of Quality Assurance and Clinical Operations roles within 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.
Excellent interpersonal and collaboration skills
Outstanding organizational skills
Excellent written and oral communication skills
Ability to operate in a fast-paced, multi-disciplinary industrial environment.