A remote QA role at BridgeBio Pharma.
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Original listing text, shown exactly as published by the company.
The Manager, QA Operations will serve as the primary quality owner for commercial packaging operations at assigned contract service providers (CSPs). You will ensure GMP compliance across day-to-day operations, manage batch record review and disposition activities, and serve as the quality partner to internal and external stakeholders. The ideal candidate brings expertise in commercial packaging and release operations, with a background that includes process validation and product launch support.
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Serve as the quality lead for commercial packaging operations at assigned CSPs, providing oversight across primary/secondary packaging, labeling, and serialization to ensure GMP and GDP compliance.
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Review executed batch records and compile batch documentation packages to support lot disposition and market release.
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Provide quality review of deviations, change controls, CAPAs, and risk assessments related to packaging operations.
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Review and provide quality input on tech transfer, process validation, and shipping qualification protocols and reports through preparation, execution, and closure.
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Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution
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Support review of CMC sections and regulatory filings.
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Author, review, and maintain QA Operations SOPs and controlled documents.
Where You'll Work
This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office or a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
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Bachelor’s degree in a scientific discipline with 6+ years of experience within a biopharmaceutical company and at least 4+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment.
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Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing and packaging operations (including serialization) in the United States and globally in support of global commercial production activities.
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Strong communication and collaboration skills with the ability to influence stakeholders in a matrix environment.
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Ability to exercise good judgment and make decisions that align with organizational objectives.
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Results-driven mindset, taking initiative and ownership of assigned tasks.
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Demonstrated flexibility and adaptability in a dynamic, rapidly growing environment.
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Commitment to continuous improvement and embracing innovative approaches in daily work.
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Up to 15% domestic and international travel required.
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary$135,700—$175,000 USD
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial & Rewards
Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Subsidized lunch and parking on in-office days
Health & Well-Being
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
BridgeBio Pharma
QA
62 open roles on Sydicom
BridgeBio Pharma is a biopharmaceutical company focused on discovering and developing precision medicines. They aim to address genetic diseases and genetically driven cancers with high unmet medical needs.
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