BridgeBio Pharma, Inc. logoBridgeBio Pharma, Inc. logo

Senior Manager, Quality Assurance Operations - Product Release

BridgeBio Pharma, Inc.San Francisco - 1800 Owens
On-site Full-time $160.2K/yr - $185.5K/yr

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Experience Level

Senior Level Manager

Qualifications

Qualifications- Bachelor’s degree in a relevant field.- Proven experience in quality assurance operations within the pharmaceutical or biotechnology sectors.- Strong knowledge of cGMP regulations and quality systems.- Exceptional attention to detail and analytical skills.- Excellent communication and interpersonal skills.- Ability to work collaboratively in a fast-paced environment.

About the job

Innovators Wanted 

Are you ready to tackle challenges that seem impossible? If this excites you, we encourage you to continue reading.
 
In 2015, we revolutionized the biotech industry by adopting a “moneyball for biotech” strategy, which combines promising academic research and projects under a unified financial framework to mitigate risk and foster innovation. This approach empowers small teams of experts to drive scientific breakthroughs.
 
At BridgeBio, we are committed to addressing rare diseases and developing transformative medicines for patients with unmet needs as swiftly as possible. Together, we explore uncharted territories, challenge norms, and encourage individuals to innovate solutions. If you are someone who thinks outside the box, we invite you to collaborate with leading minds in the industry. Together, we will ask “why not?” and redefine the future of biopharmaceuticals. We champion curiosity and experimentation, including the ethical and thoughtful application of AI to enhance clarity, speed, and work quality.
 

Key Responsibilities

Lead the management of lot release activities at our Contract Manufacturing Organizations (CMOs). As the QA Operations lead, you will oversee the review of manufacturing batch records, certificates of analysis, and the issuance of certificates of compliance. The Senior Manager, QA Operations - Product Release will ensure adherence to cGMPs and serve as the technical quality reviewer for deviations, change records, protocols, and CAPAs related to Calcilytix or other BridgeBio affiliates as necessary.

About BridgeBio Pharma, Inc.

BridgeBio Pharma, Inc. is a pioneering biotech company dedicated to developing innovative therapies for patients suffering from rare diseases. We combine scientific expertise with a unique financial model to accelerate the discovery and delivery of life-changing medicines.

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