Senior Quality Assurance Specialist – Computer Systems, Data Integrity

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Manage Computer System Validation (CSV) activities for newly implemented and updated systems throughout the software life cycle.

• Collaborate with IT and system stakeholders on validation strategies, documentation, and deliverables.

• Organize and execute audits of IT and technology vendors.

• Analyze audit findings and validation reports to identify compliance gaps and system risks.

• Engage in root cause analysis sessions and endorse effective Corrective and Preventive Actions (CAPAs) with cross-functional subject matter experts (SMEs).

• Support risk assessments for new and proposed technologies, including contributions to the AI advisory team.

• Develop and authorize internal Standard Operating Procedures (SOPs) and processes for computerized systems, ensuring data integrity and compliance with data privacy regulations.

• Guarantee documentation for CSV and Data Integrity projects, which includes risk control matrices, compliance assessments, process narratives, testing, issue evaluation, and reporting.

• Oversee daily compliance operations, which encompass client and vendor IT questionnaires, metrics reporting, responses to audit findings, internal audits, and document reviews.

• Conduct qualification reviews for IT suppliers.

• Ensure lifecycle management of GxP computerized systems in accordance with Quality Management System (QMS) policies, documentation, and change control procedures.

• Prepare Key Performance Indicators (KPIs) for management quality reporting and assist with Veeva Vault workflows, reporting, and configurations.

• Identify and implement ongoing quality improvement initiatives across computerized systems.

• Stay updated on regulatory and IT compliance developments and best practices.

⛳️ Requirements

• Bachelor’s degree in information technology or a related field.

• 6 years of pertinent experience.

• 4+ years of experience in at least one regulatory environment, including FDA 21 CFR Part 11, EU Annex 11, ISO 27001, SOX, HIPAA, HITECH, CLIA, CAP, or GCP.

• Experience in clinical trials as well as clinical laboratory, biotech, or pharmaceutical settings.

• Familiarity with computerized systems lifecycle and data integrity policies and procedures.

• Proficiency with core IT applications in regulated environments, including Veeva and LIMS.

• Competent in Microsoft Office applications, including word processing, spreadsheets, PowerPoint, MS Project, and database software.

• Capable of working both independently and collaboratively within cross-functional teams.

• Ability to fulfill quality and regulatory requirements while addressing business needs.

• Preferred qualifications include recognized IT auditor status, Certified Auditor accreditation, or information security certifications such as CISA, QICA, CISSP, CRISC, ISO 27001 Lead Auditor, or SSCP.

• No supervisory responsibilities are required.

• Minimal travel is necessary.

🏝️ Benefits

• Minimal travel requirement.

• Remote work arrangement.