Director of Quality Assurance - Combination Product

THE COMPANY

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.

SPECIAL ADVISORY

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THE ROLE

Reporting to the Executive Director, Quality Systems, the Director of Quality Assurance - Combination Product will lead quality activities related to combination products supporting our biologics pipeline. This is a hands-on role in a small, agile company environment-ideal for someone who thrives in building and executing as much as directing. The successful candidate will play a critical role in ensuring commercial readiness, process performance qualification (PPQ) support, oversight of our prefilled syringe products, and the development and implementation of our auto-injector delivery system. Additionally, this role will strengthen and mature the Combination Product Quality Management System (QMS) to meet regulatory expectations and enable successful product launch.

THE RESPONSIBILITIES

• PPQ & Commercial Readiness

Provide QA leadership for PPQ activities, ensuring compliance with global regulatory requirements (FDA, EMA, ICH, ISO 13485, 21 CFR 4).

Lead QA oversight for device / auto-injector development, qualification, and implementation.

Enhance and maintain the device / combination product QMS, aligning it with biologics GMP requirements.

Partner closely with development, regulatory affairs, CMC, supply chain, and device engineering teams to ensure quality requirements are embedded early.

THE QUALIFICATIONS

SALARY & LEVEL

89bio considers a range of factors when determining salary and level. These considerations mean actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $230,000 - $240,000.

89bio's role / level assessment approach involves assessing candidates during the interview process before confirming the level / title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as : education, experience, qualifications, geographic location, transferable skills, licenses / certifications and other job-related factors permitted by law.

THE PERKS

CONDITIONS OF EMPLOYMENT

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and / or to perform essential job functions where the requested accommodation does not impose an undue hardship.

Notice to Recruiters : To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.