Quality Analyst – IT Solutions

Quality Analyst – IT Solutions is responsible for the administration, configuration, support, and continuous improvement of enterprise systems used for Quality, Regulatory, and Compliance operations. The role acts as an application specialist for critical platforms such as eQMS, RIMS, Document Management, Audit & Compliance systems, and other GxP-regulated applications.

The position ensures that Quality and Regulatory applications remain secure, reliable, compliant, and maintained in a validated state. The Quality Analyst works closely with IT, Quality Assurance, Regulatory Affairs, business stakeholders, software vendors, and auditors to support system access, troubleshooting, validation, documentation, system changes, training, and data integrity.

The role requires strong knowledge of GxP, Computer System Validation (CSV), FDA 21 CFR Part 11, ALCOA+, ISO 9001, ISO 13485, electronic records, electronic signatures, and global regulatory requirements.

Key Responsibilities

System Administration & Configuration

• Administer and configure Regulatory and Quality applications, including eQMS, RIMS, Document Management Systems (DMS), and Audit & Compliance platforms.
• Manage user accounts, roles, permissions, security groups, and role-based access controls.
• Configure workflows, business rules, fields, metadata, and application settings according to approved requirements.
• Lead or coordinate system upgrades and vendor quarterly release activities.
• Support minor system enhancements and application backlogs, including custom reports, Single Sign-On (SSO), security policy implementation, and configuration improvements.
• Perform routine system health checks, maintenance activities, and monitoring.
• Ensure applications remain in a compliant and validated state.

Regulatory & Quality Systems Support

• Support systems used for critical Quality and Regulatory processes, including CAPA, deviations, audits, submissions, document control, SOP management, and training.
• Ensure reliable system availability and functionality for Quality and Regulatory teams.
• Support electronic records, electronic signatures, audit trails, and controlled-document requirements.
• Assist with implementation of controlled system changes in accordance with approved Quality and IT procedures.
• Apply regulatory and quality requirements to system configuration and operational processes.

Compliance, Validation & Documentation

• Maintain and support Computer System Validation (CSV) documentation, including:
  • User Requirements Specifications (URS)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Traceability matrices
  • Risk assessments
  • Change controls
• Support validation activities throughout the system lifecycle.
• Ensure systems comply with applicable GxP and data integrity requirements.
• Support internal audits, external audits, regulatory inspections, and compliance reviews.
• Maintain accurate SOPs, work instructions, system guides, validation documents, and system records.
• Ensure documentation is maintained in accordance with document-control requirements.

Incident & Technical Support

• Provide Tier 2 and Tier 3 application support for Regulatory and Quality systems.
• Troubleshoot application errors, workflow failures, configuration issues, access problems, and data inconsistencies.
• Investigate recurring incidents and identify potential root causes.
• Escalate complex issues to IT infrastructure teams, application managers, software vendors, or other stakeholders as required.
• Manage incidents, service requests, problems, and changes in accordance with ITIL processes and SLAs.
• Maintain appropriate records of incidents, resolutions, and system changes.

Training & Change Management

• Develop and maintain user training materials, onboarding resources, system guides, and work instructions.
• Deliver application training to new and existing users.
• Communicate system upgrades, new functionality, configuration changes, and release impacts to stakeholders.
• Promote consistent and compliant use of Regulatory and Quality applications across the organization.
• Support organizational change-management activities related to application enhancements and system releases.

Vendor & Stakeholder Management

• Coordinate with software vendors to resolve technical issues and implement approved enhancements.
• Participate in requirements gathering, solution evaluation, testing, and implementation activities.
• Work closely with Quality Assurance, Regulatory Affairs, IT, business users, and other cross-functional teams.
• Support vendor quarterly release assessments and implementation activities.
• Assist with tracking software licenses, renewals, and smaller application support contracts.

Data Governance & Reporting

• Maintain the accuracy, consistency, security, and integrity of data within Regulatory and Quality systems.
• Support implementation and monitoring of ALCOA+ data integrity principles.
• Review audit trails, system records, and access controls where required.
• Develop and maintain reports, dashboards, compliance metrics, and system performance indicators.
• Provide data and system analysis to support audits, regulatory submissions, management reviews, and Quality initiatives.

System Monitoring & Continuous Improvement

• Monitor application availability, system performance, and incident trends.
• Identify recurring problems, system risks, and opportunities for improvement.
• Recommend enhancements that improve system reliability, usability, compliance, and operational efficiency.
• Participate in continuous improvement projects involving Quality and Regulatory technology.
• Support proactive risk identification and mitigation activities.

Job Requirements

• Bachelor’s degree in Computer Science, Information Technology, Life Sciences, Quality, Regulatory Affairs, or a related discipline.
• ITIL Foundation certification is required.
• Veeva Vault certification is required.
• Training or certification in GxP, Computer System Validation (CSV), and FDA 21 CFR Part 11 is preferred.

Experience

• 3–5+ years of experience administering Regulatory, Quality, Compliance, or other GxP-validated enterprise systems.
• Experience with one or more of the following is highly desirable:
  • eQMS: TrackWise, Veeva QMS, Esko Pulse
  • RIMS: Regulatory Information Management Systems
  • Document Management: SharePoint DMS, Veeva QDocs, OpenText
  • Audit and Compliance applications
• Practical experience supporting validated systems and validation lifecycle activities.
• Experience with URS, IQ/OQ/PQ, traceability matrices, risk assessments, and change controls.
• Experience with application configuration, workflow administration, role-based security, and reporting.
• Experience supporting enterprise software releases, upgrades, and system enhancements.

Technical & Regulatory Knowledge

• Strong understanding of GxP requirements and Computer System Validation (CSV).
• Knowledge of FDA 21 CFR Part 11, electronic records, and electronic signatures.
• Understanding of ALCOA+ data integrity principles.
• Knowledge of ISO 9001 and ISO 13485 requirements.
• Familiarity with FDA, EMA, ICH, and other applicable global regulatory guidelines.
• Ability to interpret regulatory requirements and translate them into practical system and operational controls.
• Strong knowledge of role-based access management and application security.
• Understanding of integration patterns between enterprise applications such as Veeva, SAP, and Argus.
• Knowledge of Quality Management and Regulatory Affairs processes.
• Understanding of eQMS, RIMS, DMS, Audit Management, and Compliance systems.

Key Skills

• Application Administration
• eQMS Administration
• Veeva Vault
• Regulatory Information Management
• Quality Management Systems
• Computer System Validation (CSV)
• GxP Compliance
• FDA 21 CFR Part 11
• ALCOA+ Data Integrity
• ITIL Service Management
• Workflow Configuration
• User Access Management
• Role-Based Security
• Incident & Problem Management
• Change Management
• System Validation
• Audit & Compliance
• Data Governance
• Technical Troubleshooting
• Vendor Management
• Reporting & Analytics

Personal Attributes

• Strong analytical and methodical problem-solving skills.
• Excellent attention to detail and documentation discipline.
• Ability to translate technical and system concepts into clear business language.
• Strong communication and stakeholder-management skills.
• Ability to work effectively under pressure, particularly during audits, inspections, and critical system incidents.
• Proactive approach to identifying risks and improving system performance.
• Strong collaborative mindset with the ability to work across IT, Quality, Regulatory, and business functions.
• High level of accountability, ownership, and commitment to compliance.
• Ability to manage multiple priorities while maintaining accuracy and quality.

IT & Software Jobs → Business Systems / Application Support → Quality & Regulatory IT