What are the responsibilities and job description for the Associate/ Director, Quality Assurance position at GondolaBio LLC?
Job Description
Job Description
Description : About GondolaBio
GondolaBio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. Originally launched as BridgeBioX, a subsidiary of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. The company aims to leverage cutting-edge biological research to create breakthrough medicines addressing high unmet needs across multiple therapeutic areas, including neurology, pulmonology, cardiology, nephrology, and endocrinology. Located on the Stanford Life Sciences campus, GondolaBio fosters a unique hybrid environment where top scientists from around the world collaborate with senior leadership and advisors, blending industry expertise with academic innovation.
About BridgeBio
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20 drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
To learn more about our story and company culture, visit us at https : / / bridgebio.com
Who You Are
Reporting to the Vice President, Quality Assurance, the QC Associate Director / Director, Quality Assurance will assist in the quality oversight and management of GxP activities internally at the BBGT laboratory for GondolaBio and externally with GondolaBio vendors and service providers including, but not limited to, inspection readiness and management, quality systems management, external document review and approval including batch disposition and certificate of analysis issuance. The ideal candidate will have extensive laboratory experience working in the biotech / pharmaceutical sector
Requirements : Responsibilities
- Assists in the design, qualification / validation of laboratory instruments, equipment and software. Also, any preparation and execution of inspection readiness activities including active inspection support to ensure the GMP readiness on an ongoing basis to support phase appropriate clinical testing.
- Assists in the implementation of specifications, transfer, development and qualification / validation of test methods and procedures and issuance of certificates of analysis.
- Participate in the coordination and execution of the internal audit program. ?
- Ensures compliance to regulatory requirements and internal procedures and methods.
- Author and implement QC / QA GXP standard operating procedures (SOPs) and methods.
- Other duties as assigned or required
Education, Experience & Skills Requirements
What We Offer
