Director, Quality Assurance - Computerized System / Data Integrity

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

The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams.

THE ROLE

We are seeking a Director, Quality Assurance - Computerized System / Data Integrity to lead computerized system validation, GxP software implementation, and data integrity program. The successful candidate will oversee QA for cross-GxP validation activities ensuring they are implemented, validated, and maintained in compliance with global regulations.

THE RESPONSIBILITIES

Computerized System Validation & Data Integrity

• Lead QA oversight for the validation, implementation, and lifecycle management of GxP systems.
• Author, review, and approve validation deliverables (URS, FRS, validation plans, protocols, scripts, and reports) in alignment with GAMP 5 principles.
• Manage vendor qualification and oversight for SaaS / cloud-based platforms and outsourced service providers.
• Establish and maintain data integrity governance program, ensuring compliance with ALCOA+ principles across GxP domains.
• Ensure data traceability, authenticity, and reliability across the product lifecycle.
• Support regulatory inspections (FDA, EMA, MHRA, etc.) and sponsor / CRO audits with emphasis on computerized system validation and data integrity compliance.

Quality Systems & Risk Management

Cross-Functional Collaboration

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 $196,000-$236,000.

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.