BridgeBio is a biotechnology company designing transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Backed by Sequoia.
About the role
The Quality Systems and Risk Management Manager reports to the Sr. Manager of Quality Systems Management and plays a key supporting role in the execution and continuous improvement of the organization's risk management program and Quality Management System (QMS). This individual contributes across two core areas: Owning and leading formal risk management through risk assessments, risk registers, and the application of ICH Q9 and FMEA frameworks, and Maintaining and improving the QMS.
What they're looking for
- Bachelor’s degree or equivalent in pharmacy, science, mathematics or engineering required
- Strong experience and knowledge leading formal risk management activities in a GxP environment, including risk identification, assessment, and mitigation using tools such as FMEA, risk ranking, and ICH Q9 frameworks
- Knowledge of Lean Six Sigma Methodologies or equivalent is preferred
- Excellent analytical, problem-solving, and project management skills with keen attention to detail
- Knowledge of regulatory requirements and guidelines (e.g., FDA, ICH, EU GMP, GDP)
- Proficiency in eQMS preferably with prior Veeva experience, Microsoft Office, Excel, Google Docs, etc
More about this 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.
The Quality Systems and Risk Management Manager reports to the Sr. Manager of Quality Systems Management and plays a key supporting role in the execution and continuous...
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