Qa Engineer • Senior

Who you are

You have extensive experience in quality assurance operations, particularly in the biopharma sector, and are well-versed in cGMP regulations. Your background includes managing QA processes and collaborating with Contract Manufacturing Organizations (CMOs) to ensure compliance and quality standards are met. You thrive in environments that challenge conventional approaches and are passionate about driving innovation in the industry.

You possess strong analytical skills and attention to detail, enabling you to review manufacturing batch records, certificates of analysis, and compliance documentation effectively. Your ability to communicate complex quality assurance concepts to both technical and non-technical stakeholders makes you a valuable asset to any project team. You are proactive in identifying potential quality issues and implementing corrective actions to maintain high standards.

What you'll do

In this role, you will manage lot release activities at BridgeBio's CMOs, acting as the QA Operations lead. You will be responsible for reviewing manufacturing batch records and certificates of compliance, ensuring that all processes adhere to established cGMPs. You will represent QA Operations on internal and external project teams, participating in audits and ensuring that all quality assurance activities align with company standards.

You will also serve as the technical quality reviewer for deviations, change records, protocols, and CAPAs related to Calcilytix and other BridgeBio affiliates. Your expertise will guide the team in maintaining compliance with SOPs and Master Batch Records, ensuring that all documentation is accurate and up to date. You will collaborate closely with cross-functional teams to drive quality initiatives and support the development of life-changing medicines for patients with unmet needs.

What we offer

BridgeBio offers a competitive salary range of $160,200—$185,500 USD, reflecting the importance of this role in our mission to innovate in the biopharma space. You will work alongside some of the most respected minds in the industry, contributing to groundbreaking advancements in rare disease treatment. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse perspectives and backgrounds in our team.