Director, Quality Assurance – Computerized System / Data Integrity

About 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 focuses 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.

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.

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

Enhance and maintain the QA framework for computerized systems within the company’s overall QMS.

Manage change control for computerized systems, ensuring thorough impact assessments, validation, and implementation.

Monitor and perform periodic system reviews, identify compliance gaps, and implement CAPAs.

Maintain / update SOPs and train personnel on computerized systems, CSV, data integrity, and software lifecycle management SOPs and related regulations.

Cross‑Functional Collaboration

Partner with internal stakeholders to ensure QA oversight across all GxP systems.

Provide QA guidance and training for system owners and business users in computerized system compliance and data integrity.

Prepare for and serve as subject‑matter expert (SME) for GxP computerized systems during regulatory inspections and audits.

Qualifications

Bachelor’s or advanced degree in a scientific, engineering, or computer science discipline.

10+ years of relevant QA experience in the biopharmaceutical industry, leading risk‑based computer system validation strategies, and data integrity initiatives.

Deep working knowledge of regulatory requirements and guidance : 21 CFR Part 11, EU Annex 11, GAMP 5, ICH E6(R3) GCP, Guideline on computerized systems and electronic data in clinical trials March 2023, MHRA GxP Data Integrity Guidance and Definitions, 21 CFR Parts 210 / 211, 820, and Part 4.

Salary & Level

The expected salary range for this position based on the primary location in Northern California is $196,000–$236,000. Salary is determined by a combination of factors including education, experience, qualifications, geographic location, and other job‑related factors permitted by law.

Perks

Competitive health insurance coverage.

Women’s forum / mentoring.

Office based in the heart of San Francisco, near shops and restaurants.

Fun opportunities to engage with co‑workers in‑person and remotely.

Conditions of Employment

Background investigations are required for all positions by 89bio, consistent with applicable law.

Candidates must already hold work authorization, as visa sponsorship is not available for this role.

Legal Notice

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.

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