IT Business Systems Analyst

JSR Micro, Inc.

. Lead requirements gathering, process mapping, and gap analysis for Quality Systems, including eQMS, CAPA, Deviations, Change Management, and Audit Management .

Posted 9/24/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Systems, including eQMS, CAPA, and regulatory compliance, with a strong focus on system validation and lifecycle management. Proven ability to translate complex regulatory requirements into functional specifications while leading cross-functional teams and mentoring junior analysts.

Highest-signal resume keywords

Quality Systems AnalysisEQMS Platforms (Veeva Vault QMS, TrackWise, MasterControl)System Validation (IQ/OQ/PQ)GxP ComplianceRegulatory Knowledge (FDA 21 CFR Part 11, Annex 11)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Requirements GatheringProcess MappingGap AnalysisRisk AssessmentsChange ControlData GovernanceAnalytics for Quality MetricsDocumentation SkillsProblem-Solving SkillsSystem Integration

Soft Skills

Communication SkillsMentoringCollaborationAutonomous OperationStakeholder Alignment

Industry Keywords

Biopharmaceutical Quality ProcessesRegulated Software Development LifecycleGlobal Regulatory ExpectationsMulti-Region InitiativesQuality Metrics and KPIs

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Lead requirements gathering, process mapping, and gap analysis for Quality Systems, including eQMS, CAPA, Deviations, Change Management, and Audit Management
Translate business and regulatory requirements into functional and technical specifications
Partner with Quality and business operations to design compliant and efficient system solutions
Ensure systems comply with GxP, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles
Support system validation activities, including validation planning, risk assessments, IQ/OQ/PQ, and change control
Act as a subject matter expert for Quality Systems during audits and inspections
Own or support system lifecycle activities, including implementation, upgrades, enhancements, and decommissioning
Identify opportunities for automation, standardization, and system integration
Evaluate vendor solutions and support system selection
Advise Quality leadership on system capabilities and roadmap planning
Lead cross-functional workshops and working groups
Mentor junior analysts and contribute to business analysis and validation best practices
Support data governance, reporting, and analytics for Quality metrics and KPIs
Manage complex, multi-region or multi-site Quality System initiatives
Operate autonomously with minimal supervision and resolve non-routine problems requiring judgment, regulatory knowledge, and stakeholder alignment

Requirements

What you’ll need

Bachelor’s degree in Information Systems, Engineering, Life Sciences, or related discipline
6–10 years of experience in business systems analysis
At least 4–6 years supporting GxP-regulated Quality Systems in the pharmaceutical or biotechnology industry
Proven experience with eQMS platforms such as Veeva Vault QMS, TrackWise, or MasterControl
Strong background in system validation and regulated Software Development Lifecycle methodologies
Deep understanding of biopharmaceutical Quality processes and regulatory expectations
Strong analytical, documentation, and problem-solving skills
Ability to communicate complex technical and regulatory concepts to non-technical stakeholders
Experience working in global, matrixed organizations
Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations

Benefits

Comp & perks

EEO/AA employer
Equal employment opportunity for qualified applicants regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status
At-will employment