Director, Quality Assurance - GxP (GCP) Remote
Axsome Therapeutics Inc- Full Time
- Senior (5 to 8 years)
Abata Therapeutics
Candidates should possess a Bachelor’s degree in Computer Science, Information Systems, or a related field, with a minimum of 8 years of experience in Computer System Validation (CSV) within a regulated environment, preferably in the pharmaceutical or biotechnology industry. Strong knowledge of GxP regulations, including 21 CFR Part 11, is essential, along with experience in leading and managing validation projects.
As the Director, Computer System Validation - Quality Assurance (CSV QA), you will lead and manage the CSV QA function, ensuring GXP computer systems are validated in compliance with relevant regulatory requirements. You will develop and implement CSV strategies, policies, and processes, oversee the planning and execution of validation activities, collaborate with cross-functional teams, lead risk mitigation efforts, and drive improvements in CSV and data integrity processes. Additionally, you will ensure validation documentation is maintained in compliance with regulatory requirements.
Develops therapies for autoimmune diseases
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.