IT Quality Assurance Specialist

United Pharma; North Carolina; On-site; USD 115,000 - 150,000; Full time

Job summary

United Pharma is seeking an IT Quality Assurance Specialist / Lead in North Carolina to ensure GxP compliance for computerized systems across manufacturing. You will oversee CSV, data integrity, change control, deviations, CAPAs and supplier governance, while guiding teams in risk-based validation and quality processes.

The role collaborates with Quality, IT, Manufacturing, Engineering and Regulatory Affairs to maintain validated, inspection-ready systems and drive digital-transformation

Qualifications

• Bachelor’s or master’s degree in Computer Science, IT, Engineering, Pharmacy, Life Sciences or related discipline.
• 5–10 years of IT Quality Assurance, CSV or GxP IT compliance experience.
• Experience in regulated life-sciences manufacturing environments and audits.

Responsibilities

• Provide ITQA oversight for GxP computerized systems across manufacturing operations.
• Review validation deliverables (IQ/OQ/PQ, validation plans, traceability matrices).
• Assess changes, incidents, deviations, CAPAs and supplier governance for compliance.
• Support audits, inspections and evidence readiness.

Skills

IT Quality Assurance

Computer System Validation

GxP Compliance

Regulatory Audits

Documentation & QA Processes

Education

Bachelor’s or Master’s in CS/IT/Engineering/Pharma/Life Sciences

Tools

SAP

MES

LIMS

QMS

DMS

SCADA

BMS

EMS

Historians

Job description

Position: IT Quality Assurance Specialist / Lead

Location: NC

Role Summary

The ITQA professional will ensure that computerized systems, IT infrastructure and digital technologies used across pharmaceutical manufacturing operations remain compliant with applicable GxP requirements throughout their lifecycle. The role will provide independent quality oversight for system validation, data integrity, change control, deviations, periodic reviews, access management, backup and recovery, cybersecurity controls and supplier governance.

The position will collaborate with Quality, IT, Manufacturing, Engineering, QC, Warehouse, Automation and business process owners to maintain systems in a validated and inspection-ready state.

Key Responsibilities

Computerized System Validation and Assurance

• Provide ITQA oversight for GxP computerized systems, including ERP/SAP, MES, LIMS, QMS, DMS, laboratory systems, manufacturing applications, historians, BMS, EMS, SCADA and other automation platforms.
• Review and approve validation lifecycle deliverables such as:
• GxP and data-integrity assessments
• User Requirement Specifications
• Validation plans and summary reports
• Functional and design specifications
• Configuration specifications
• IQ, OQ and PQ protocols and reports
• Requirements traceability matrices
• System release and retirement documentation
• Ensure validation activities follow a risk-based approach aligned with GAMP 5 and applicable internal procedures.
• Support the transition from traditional CSV practices to Computer Software Assurance, where appropriate.

IT Quality and Compliance Oversight

• Ensure IT systems and infrastructure comply with applicable GxP regulations, company quality standards and approved procedures.
• Review and approve GxP-related IT changes, incidents, deviations, CAPAs and problem investigations.
• Assess the quality and compliance impact of proposed system changes, upgrades, patches, migrations and integrations.
• Monitor the validated state of computerized systems throughout their operational lifecycle.
• Participate in system implementation, cloud adoption, infrastructure modernization and digital-transformation projects.
• Ensure appropriate quality oversight of legacy-system remediation and system decommissioning.

Data Integrity and Electronic Records

• Evaluate systems against ALCOA+ data-integrity principles.
• Ensure adequate controls for electronic records and electronic signatures.
• Review controls relating to:
• User access and role-based privileges
• Administrator and privileged accounts
• Segregation of duties
• Audit trails and audit-trail review
• Date and time synchronization
• Data backup, restoration and archival
• Record retention and retrieval
• Interface and data migration controls
• Disaster recovery and business continuity
• Support investigations involving electronic records, audit trails, unauthorized access or suspected data-integrity concerns.

Quality System Activities

• Review and approve IT-related SOPs, policies, work instructions and technical procedures.
• Participate in deviation investigations, root-cause analysis and CAPA development.
• Track IT compliance actions and CAPAs through effective closure.
• Coordinate periodic reviews of GxP computerized systems and infrastructure.
• Support risk-based evaluation of obsolete technologies, unsupported platforms and compliance vulnerabilities.
• Develop and monitor IT quality metrics, compliance dashboards and management-review inputs.

Audit and Inspection Readiness

• Support internal audits, supplier audits, regulatory inspections and customer assessments.
• Prepare and maintain validation and compliance evidence in an inspection-ready state.
• Coordinate responses to observations related to computerized systems, electronic records and IT controls.
• Conduct IT GxP compliance assessments and follow up on remediation actions.
• Assist in preparing responses to regulatory observations and ensuring timely CAPA implementation.

Supplier and Cloud Governance

• Participate in qualification and periodic assessment of software, cloud, infrastructure and managed-service providers.
• Review supplier validation documentation, quality agreements, service-level commitments and security controls.
• Ensure supplier responsibilities are clearly defined for data integrity, incident management, change notification, backup, recovery, availability and record retention.
• Evaluate the suitability of vendor documentation for use within the regulated organization’s validation framework.

Cross-Functional Collaboration

• Work closely with QA, IT, QC, Manufacturing, Engineering, Warehouse, Regulatory Affairs, Automation and system owners.
• Guide project teams on GxP, validation and data-integrity requirements.
• Deliver training on computerized system compliance, IT quality processes and regulatory expectations.
• Promote quality-by-design and risk-based decision-making across technology initiatives.

Required Qualifications

• Bachelor’s or master’s degree in Computer Science, Information Technology, Engineering, Pharmacy, Life Sciences or a related discipline.
• 5–10 years of experience in IT Quality Assurance, Computerized System Validation, Computer Software Assurance or GxP IT compliance.
• Relevant experience within pharmaceutical, biologics, medical-device or other regulated life-sciences manufacturing environments.
• Practical knowledge of the computerized-system lifecycle, validation documentation and quality-management processes.
• Experience supporting audits and regulatory inspections is preferred.

Required Knowledge and Skills

• Strong understanding of:
• FDA 21 CFR Parts 11, 210 and 211
• EU GMP Annex 11
• GAMP 5
• ICH Q9 and ICH Q10
• PIC/S data-integrity expectations

Computer Software Assurance principles

• Data privacy, cybersecurity and business-continuity controls affecting GxP systems
• Experience with systems such as SAP, MES, LIMS, QMS, DMS, CDS, SDMS, laboratory instruments, SCADA, PLC, BMS, EMS and data historians.
• Working knowledge of change control, deviation, CAPA, incident, problem and configuration-management processes.
• Ability to evaluate infrastructure components such as servers, databases, networks, virtualization, cloud platforms, backup solutions and cybersecurity controls from a GxP perspective.
• Strong technical writing, analytical, communication and stakeholder-management skills.
• Ability to manage multiple systems and projects while maintaining quality and compliance priorities.

Preferred Certifications

• GAMP 5 or computerized-system validation certification
• ASQ Certified Quality Auditor or equivalent
• ITIL Foundation
• ISO 27001, CISA, CISSP or other relevant IT assurance certification
• Project-management or Agile certification
• Regulatory and quality-system awareness
• Independent quality judgment
• Risk-based decision-making
• Attention to detail and documentation discipline
• Root-cause analysis and problem-solving
• Cross-functional collaboration
• Audit and inspection readiness
• Effective communication and stakeholder influence

Key Performance Indicators

• Timely review and approval of validation and IT quality deliverables
• Compliance with validation, change-control and periodic-review schedules
• Timely closure and effectiveness of deviations and CAPAs
• Reduction in repeat IT compliance and data-integrity observations
• Maintenance of GxP systems in a validated and inspection-ready state
• Effectiveness of access, audit-trail, backup and recovery controls
• Timely completion of supplier assessments and compliance actions
• Audit and regulatory-inspection outcomes