Job Description
An innovative, clinical-stage biotechnology company focused on developing transformative therapies for patients with serious genetic diseases is seeking a Senior IT Business Analyst to support its regulated GxP systems landscape.
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This individual will partner closely with Quality Assurance, Regulatory Affairs, Manufacturing, Process Development, and Quality Control to ensure business requirements are translated into compliant IT solutions while maintaining validation, data integrity, and inspection readiness across GLP/GMP computerized systems.
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Responsibilities
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- Partner with QA and Regulatory teams to support GxP computerized systems, including Quality Management Systems (QMS) and regulated documentation platforms.
- Gather and document business requirements through workshops, interviews, process mapping, and user stories.
- Lead business analysis activities for medium to large IT initiatives.
- Support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities throughout the system lifecycle.
- Author and review validation documentation including URS, traceability matrices, validation plans, test scripts, and summary reports.
- Coordinate change control, validation, and qualification activities for laboratory, manufacturing, and regulated systems.
- Maintain compliant system administration, user access, and data integrity practices.
- Support audits and regulatory inspections by ensuring validation documentation and system records are inspection-ready.
- Collaborate with internal stakeholders and external vendors to maintain validated systems and operational support.
- Contribute to long-term IT roadmaps and provide data-driven business insights.
- Train business users on compliant use of regulated computerized systems.
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Requirements
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- Bachelor's degree in Information Systems, Life Sciences, Engineering, or a related discipline (Master's preferred).
- 8–12 years of IT Business Analysis experience.
- 5+ years supporting GLP/GMP regulated environments.
- Strong experience with CSV/CSA methodologies, GAMP 5, validation planning, risk assessments, testing, and change control.
- Experience translating laboratory, manufacturing, quality, or regulatory business processes into compliant system requirements.
- Experience supporting regulatory inspections and maintaining validated systems.
- Ability to work cross-functionally with QA, Regulatory, Manufacturing, IT, and external vendors.
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Desired Technical Knowledge
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- GLP/GMP computerized systems
- Quality Management Systems (QMS)
- Computerized System Validation (CSV)
- Computer Software Assurance (CSA)
- GAMP 5
- 21 CFR Part 11
- ALCOA+ data integrity principles
- IQ/OQ/PQ qualification activities
- Change Control
- Risk Assessments
- Validation Documentation
- Inspection Readiness
- Data Integrity
- User Access Management
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Location: Cambridge, Massachusetts
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Employment Type: Contract