- Company Name
- 89bio
- Job Title
- Director, Quality Assurance - Computerized System/Data Integrity
- Job Description
-
**Job Title:** Director, Quality Assurance – Computerized Systems/Data Integrity
**Role Summary:**
Leads the quality assurance function for computerized system validation, GxP software implementation, and data‑integrity governance across the organization. Ensures all computerized systems and associated data meet global regulatory requirements throughout their lifecycle and supports regulatory inspections and audits.
**Expectations:**
- Provide strategic QA oversight for all GxP computerized systems.
- Maintain compliance with ALCOA+ data‑integrity principles and relevant regulations.
- Drive continuous improvement of the computerized‑system QMS and risk‑based validation approaches.
- Serve as subject‑matter expert during inspections, audits, and cross‑functional projects.
**Key Responsibilities:**
- Lead validation, implementation, and lifecycle management of GxP systems (authoring URS, FRS, validation plans, protocols, scripts, reports).
- Manage vendor qualification and oversight for SaaS/cloud platforms and outsourced service providers.
- Establish and sustain a data‑integrity governance program across all GxP domains.
- Oversee change control, periodic system reviews, gap analysis, and CAPA execution for computerized systems.
- Develop, maintain, and train on SOPs related to CSV, data integrity, and software lifecycle management.
- Collaborate with internal stakeholders to provide QA guidance, training, and support for system owners and business users.
- Prepare and act as SME for regulatory inspections (FDA, EMA, MHRA, etc.) and sponsor/CRO audits.
**Required Skills:**
- Deep knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH E6(R3) GCP, MHRA GxP Data Integrity Guidance, 21 CFR Parts 210/211, 820, 4.
- Proven experience designing and executing risk‑based computer system validation strategies.
- Strong vendor management and SaaS/cloud platform oversight capabilities.
- Expertise in data‑integrity principles (ALCOA+), traceability, and audit readiness.
- Excellent communication, training, and cross‑functional collaboration skills.
- Ability to lead change control, perform impact assessments, and manage CAPAs.
**Required Education & Certifications:**
- Bachelor’s degree (or higher) in a scientific, engineering, or computer science discipline.
- Minimum 10 years of QA experience in the biopharmaceutical industry, with a focus on computerized system validation and data integrity.
- Relevant certifications (e.g., Certified Quality Auditor, Certified Professional in GxP, or similar) are preferred but not mandatory.
San francisco, United states
On site
Senior
24-10-2025