What are the responsibilities and job description for the Senior/ Manager, Quality Assurance position at GondolaBio LLC?

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 VP, Quality Assurance, the Manager / Senior Manager, Quality Assurance will assist in the quality oversight and management of internal and external GxP Quality Systems and processes including, but not limited to : Document Control, Training, and QMS management. The ideal candidate will have quality assurance experience working in the biotech / pharmaceutical sector as well as batch review and release.

Requirements : Responsibilities

Management and maintenance of quality systems such as Document Control, Change Control, Deviations, CAPA, and Effectiveness Checks.
Implement Master Batch Records, Review executed batch records, release drug product.
Author and implement QA GXP standard operating procedures (SOPs).
Develop and deliver training on GXP SOPs and systems. ?
Assists in the implementation, management, maintenance, and evaluation of GondolaBio’s Quality Management Systems.
Support computer system validation, including the development and execution of system validation plans and performance qualification testing.
Ability to effectively multi-task to meet deadlines and commitments. ?
Other duties as assigned or required

Education, Experience & Skills Requirements

Bachelor's degree in a scientific discipline or equivalent experience

Minimum of 5 years pharmaceutical industry experience in Quality Assurance or other relevant roles.

Experience with sterile injectable manufacturing and QA release preferably with gene therapy, but biologics and other forms will be considered.

Knowledge of applicable GXP regulations (e.g., USP, CFRs and ICH).

Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors.

A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.

Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events.

Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges.

Other skills and abilities as required. ?

Travel – varies at 10-25% based on needs

What We Offer

Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts

A culture inspired by our values : put patients first, think independently, be radically transparent, every minute counts, and let the science speak

An unyielding commitment to always putting patients first. Learn more about how we do this here

A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science

A place where you own the vision – both for your program and your own career path

A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game

Access to learning and development resources to help you get in the best professional shape of your life

Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)

Flexible PTO

Rapid career advancement for strong performers

Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time

Partnerships with leading institutions

Commitment to Diversity, Equity & Inclusion

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