Sr. Mgr., Quality Management Systems
About the role
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. What You’ll Do Reporting to the Associate Director, Quality Management Systems, the Senior Manager, Quality Management Systems will lead the administration, governance, and continuous improvement of the company’s Quality Risk Management (QRM) program and serve as a trained backup for Document Control and the GxP Training Program.
Responsibilities
- Lead the development, deployment, and continuous improvement of the QRM program, including procedures, templates, tools, and risk registers.
- Facilitate cross-functional risk assessments using appropriate methodologies, including fit-for-purpose tools (e.g. risk ranking and filtering, hazard analysis, F