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BridgeBio Pharma
Sr. Manager, Analytical Development
Career Insights for Director of Quality Assurance
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What they do
A Director of Quality Assurance oversees and directs the overall operations of quality assurance within a company to ensure continuous improvement and compliance.
$169,784 / year median in California
-1% projected decline
Job Description
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 BridgeBio seeks a motivated, knowledgeable, and hands-on analytical development scientist and quality control professional to manage analytical development, QC, and stability activities at contract manufacturing sites and to contribute to the development of clinical assets and regulatory submissions. This position requires close collaboration with the Drug Substance, Drug Product, and Quality Assurance groups. This candidate should know the various analytical techniques across modalities. In addition, this individual should be experienced in test method development, analytical method transfer, phase-appropriate method validation, and stability program management (including data trending and analysis) for both drug substances and drug products. A thorough understanding of relevant ICH quality guidelines and excellent communication skills (both verbal and written) is required. Responsibilities
- Management of contract drug substance and drug product analytical development and quality control activities and timelines
- Authoring and review of analytical method transfer and validation protocols and reports
- Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications
- Review stability protocols and monitor various stability programs
- Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings
- Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify root causes and implement CAPAs
- Develop, revise, and approve SOPs and QC processes, enhancing compliance, consistency, and operational efficiency Where You'll Work This is a hybrid role and requires in-office collaboration 2x per week in our San Francisco office.