Associate Director – QA Computer Systems

Rezolute, Inc.

. Lead validation planning, execution, and documentation for new and existing systems, including EDMS, QMS, ERP, and RIM .

Posted 9/18/2026full-timeRemote • United StatesSenior💰 $170,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in computer system validation, including the creation and execution of validation deliverables, while ensuring compliance with FDA regulations and maintaining data integrity. Proficient in managing vendor relationships and improving system lifecycle processes across various departments.

Highest-signal resume keywords

Computer System ValidationFDA 21 CFR Part 11Veeva Vault ExperienceQuality AssuranceValidation Methodologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation PlanningRisk AssessmentsTest ScriptsTrace MatricesValidation PlansSoftware Development Lifecycle (SDLC)Electronic Validation ManagementGxP RegulationsChange ControlsAudits

Soft Skills

CollaborationProject ManagementCommunicationLeadership

Tools & Technologies

Veeva VaultSharePointMS-WordExcelPowerPointAdobe Acrobat

Certifications & Qualifications

Veeva Vault Administrator

Industry Keywords

GAMP 5EU GMP Annex 11Regulated IndustriesQuality AssuranceIT Quality

Tech Stack

Tools & technologies

ERPSDLCVault

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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