Our client is a patient-centered, clinical-stage biopharmaceutical company committed to developing cell therapies for patients with autoimmune diseases. They leverage advanced T cell engineering to suppress and eliminate autoreactive immune cells, addressing the root cause of autoimmune and inflammatory diseases. By joining this pioneering team of scientists, industry veterans, and healthcare visionaries, you'll contribute to transforming the treatment landscape for autoimmune diseases.
We are seeking a highly motivated Senior Manager of Computerized Systems Quality Assurance (CSQA) for our client's Quality organization. In this role, you will lead the development and implementation of a robust Software Quality Assurance (CSA) program, focusing on GAMP 5 and Health Authority compliance. Your responsibilities will include ensuring compliance for systems managed internally as well as assessing and communicating risks associated with systems managed by contract service providers (CSPs) and partners. Upholding regulatory requirements, enhancing quality compliance, and maintaining the highest standards of quality in CSA across technical, clinical, and regulatory operations will be central to your mission.
Responsibilities:
Requirements:
Salary Range:
The salary range for this position is from $140,000 - $155,000 USD annually. Actual salary may vary based on factors such as education, experience, skills, and internal equity.
Equal Opportunity Employer:
Our client is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all employees without regard to race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected status.