Associate Director – QA Computer Systems

🕒 September 18

🇺🇸 United States – Remote

💵 $170k - $200k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Rezolute, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $96.9M Post-IPO Equity - Rezolute on 2025-04

Healthcare • Biotechnology • Pharmaceuticals

Rezolute, Inc. is a biopharmaceutical company focused on developing and delivering novel therapies for rare metabolic disorders, specifically hyperinsulinism. The company’s lead program, ersodetug, has two Phase 3 programs targeting congenital and tumor hyperinsulinism, and Rezolute conducts clinical trials, investigator-initiated studies, and publishes clinical outcomes. Rezolute also engages with patients, investors, and the medical community to improve care and quality of life for affected patients and families.

📋 Description

• Lead validation planning, execution, and documentation for new and existing systems, including EDMS, QMS, ERP, and RIM • Create, execute, and approve validation deliverables, including validation plans, risk assessments, requirements, test scripts, trace matrices, and summary reports • Identify opportunities to streamline and scale validation processes for a small, fast-growing company • Ensure data integrity principles are incorporated into computerized system processes • Support vendor qualification and inspection activities • Lead ongoing system lifecycle maintenance, including risk assessments, change controls, audits, and periodic reviews • Manage vendor contracts and licensing for computer systems where applicable • Work with IT to support and improve end users’ computer systems experience • Collaborate across QA, Clinical, Commercial, IT, Finance, and vendors • Maintain the validated state of QA computer systems through documentation, periodic reviews, project management, inspection support, and presentations

🎯 Requirements

• Bachelor's degree in computer science, information technology, engineering, or a related field (or equivalent experience) • Strong understanding of FDA 21 CFR Part 11, GAMP 5, and EU GMP Annex 11 • 10+ years’ experience in computer system validation in regulated industries • Knowledge of validation methodologies, tools, and best practices • Experience with Veeva Vault • Proven experience in quality assurance, validation, or implementation of Veeva Systems applications • Familiarity with FDA 21 CFR Part 11, EMA Annex 11, and GxP regulations • Proven experience in quality assurance, software testing, or IT quality • Knowledge of software development lifecycle (SDLC) methodologies • Ability to travel up to 15% of the time • Certification in Veeva Vault Administrator or similar credentials is a plus • Experience managing employees and contractors • Familiarity with multiple GxP systems and system implementations • Expertise in electronic validation management is a plus • Proficiency in SharePoint, MS-Word, Excel, PowerPoint, and Adobe Acrobat

🏖️ Benefits

• Annual performance bonus • Health Insurance (Medical / Dental / Vision) • Disability, Life & Long-Term Care Insurance • Holiday Pay • Tracking Free Vacation Program • 401(k) Plan Match • Educational Assistance Benefit • Fitness Center Reimbursement