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.

About the Role

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.

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.

Requirements

• Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, or a related discipline.
• 8+ years of IT Business Analysis experience supporting enterprise applications and business processes.
• 5+ years supporting GxP-regulated environments, including GLP and GMP systems.
• Hands-on experience with Computer System Validation (CSV) and Computer Software Assurance (CSA) methodologies.
• Strong knowledge of FDA 21 CFR Part 11, GAMP 5, ALCOA+, and risk-based validation approaches.
• Experience supporting Quality, Manufacturing, Laboratory, Process Development, or Validation business functions.
• Proven ability to gather requirements, analyze business processes, and translate needs into compliant technology solutions.
• Experience supporting audits, inspections, validation documentation, and regulatory inquiries.
• Demonstrated success leading cross-functional initiatives and influencing stakeholders without direct authority.
• Strong analytical, problem-solving, communication, and project management skills.

Preferred Qualifications

• Master's degree in Information Systems, Engineering, Life Sciences, or a related field.
• Experience with Quality Management Systems (QMS), document management platforms, LIMS, manufacturing systems, or regulatory affairs applications.
• Experience implementing or supporting cloud-based validated platforms.
• Certification in Business Analysis, Project Management, Quality, or Validation disciplines.

Skills

• Business Analysis
• Requirements Gathering
• GxP Compliance (GLP/GMP)
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• Quality Management Systems (QMS)
• Project Management
• Regulatory Compliance
• Stakeholder Management
• Data Integrity (ALCOA+)

Pay

The pay range for this position is $60.00 - $75.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a fully onsite position in Lexington, MA. This is a Contract position.