Senior Business Analyst

We are seeking an experienced SR IT Business Analyst & GxP Systems Manager to lead business analysis, compliance, and systems support activities across a portfolio of regulated GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) computerized systems. This role serves as a strategic IT partner to Quality Assurance (QA), Regulatory Affairs (RA/Reg Ops), Manufacturing, Quality Control, Process Development, Validation, and other GxP business functions.
The ideal candidate combines strong business analysis expertise with hands-on experience supporting validated GxP systems, Computer System Validation (CSV), Computer Software Assurance (CSA), data integrity, and regulatory compliance. This individual will play a key role in driving technology solutions that enhance operational efficiency while maintaining inspection readiness and compliance with global regulatory requirements.

Key Responsibilities

Business Analysis & Stakeholder Partnership

• Serve as the primary IT business partner for QA and Regulatory Affairs/Operations teams, supporting Quality Management Systems (QMS), quality documentation platforms, regulatory systems, and other GxP applications.
• Lead requirements gathering activities through workshops, stakeholder interviews, and process analysis sessions.
• Translate business needs into clear, testable, and compliant system requirements, user stories, process maps, data flow diagrams, and functional specifications.
• Facilitate collaboration between business stakeholders, IT teams, validation personnel, and vendors to ensure successful solution delivery.

Project & Systems Leadership

• Lead and support medium to large-scale initiatives involving regulated systems and business processes.
• Develop strategic roadmaps and long-term system improvement plans aligned with organizational objectives.
• Oversee enhancement requests, defect remediation, system upgrades, integrations, and lifecycle management activities.
• Drive prioritization efforts while balancing business value, compliance requirements, and resource constraints.

GxP Compliance, Validation & Inspection Readiness

• Partner closely with QA and Validation teams to ensure requirements remain traceable throughout the system lifecycle.
• Support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities, including:
  • User Requirements Specifications (URS)
  • Risk Assessments
  • Traceability Matrices
  • Test Scripts and Protocols
  • Validation Summary Reports
  • IQ/OQ/PQ Execution Support
• Ensure compliance with regulatory requirements including FDA 21 CFR Part 11, GAMP 5, ALCOA+, and applicable internal quality procedures.
• Maintain inspection readiness by ensuring validation documentation, change records, and supporting evidence remain current and readily accessible.

System Administration & Operational Support

• Support validated systems through proper access management, role administration, periodic reviews, and audit readiness activities.
• Coordinate system backups, data retention, archiving, and disaster recovery processes for regulated environments.
• Partner with IT infrastructure teams, vendors, and business stakeholders to maintain system reliability, availability, and security.
• Support vendor qualification, audits, and ongoing compliance monitoring activities.

Quality, Manufacturing & Laboratory Systems Support

• Provide validation and compliance oversight for laboratory, manufacturing, process development, and quality-related computerized systems.
• Collaborate with Facilities and Manufacturing teams to ensure qualification and validation requirements are incorporated into system modifications and upgrades.
• Promote best practices related to data integrity, electronic records management, and regulatory compliance.
• Conduct periodic system reviews to confirm continued validated state and fitness for intended use.

Training & Continuous Improvement

• Train business and IT users on compliant operation of GxP systems and supporting procedures.
• Identify opportunities to streamline processes and improve system effectiveness while maintaining regulatory compliance.
• Provide data analysis and actionable insights to support informed business decision-making.

Required Qualifications

• B…