Senior IT Business Analyst, GLP & GMP

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.DescriptionThe Senior IT Business Analyst, GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) Systems Manager is responsible for providing business analysis and IT systems support across Wave’s GxP computerized systems, with primary partnership to Quality Assurance (QA) and Regulatory Affairs/Regulatory Operations (RA/Reg Ops) teams. This role works with business stakeholders to elicit and document user needs, translate them into clear system requirements, and ensure solutions are implemented, qualified/validated, and maintained in a compliant state. The position represents IT in Wave’s computerized system lifecycle activities for Quality Management Systems (QMS), quality documentation, and related regulated platforms, ensuring data integrity, security, and inspection readiness. Responsibilities also include IT systems validation and compliance support of laboratory and manufacturing-related systems (e.g., instruments, skids, QC/PD software and computers) and coordination of reliable data storage, backup, archiving, and integration activities within the GxP environment. Key business partners include QA, Reg Affairs/Reg Ops, Quality Control, Manufacturing, Process Development, and Validation. This role will be based in our Lexington, MA office, with the expectation of being onsite up to five days per week.ExperienceBachelor’s degree (BS/BA) in Information Systems, Life Sciences, Engineering, or a related discipline, Master’s degree preferred8-12 years of experience in Information systems business analysis5+ years of experience supporting GxP‑regulated (GLP/GMP) environments, with demonstrated focus on compliance, validation governance, and inspection readinessHands‑on experience with computerized system validation (CSV) and Computer Systems Assurance (CSA) activities, including requirements definition, risk and impact assessments, validation planning, testing support, change control, and maintenance of validated state in alignment with GAMP 5 and internal quality proceduresProven ability to perform business process analysis for laboratory, quality, manufacturing, facilities, or process development workflows and translate regulatory and operational needs into compliant system and process requirementsExperience partnering closely with Quality Assurance, business SMEs, IT, and vendors to ensure systems and processes meet regulatory and data integrity expectationsExperience supporting audits and inspections, including preparation of validation evidence, SOP alignment, and response to auditor inquiries related to system use and controlsResponsibilitiesServe as a primary business analysis partner for QA and Reg Affairs/Reg Ops teams supporting GxP computerized systems (e.g., QMS, quality documentation, submissions/labeling support tools as applicable), including intake, triage, and prioritization of enhancements, defects, and lifecycle needsLead requirements elicitation activities (workshops, interviews) and produce fit-for-purpose deliverables such as user stories/use cases, process maps, data flow diagrams, and configuration specifications aligned to regulated practicesOversee mid to large-scale projects: Managing projects with significant business impactPartner with QA to Validation to ensure requirements are complete, testable, and traceable through the system lifecycle (from user needs through validation testing and release)Provide systems qualification/validation support for GLP and GMP systems, including contribution to validation planning, risk assessment (e.g., GAMP 5 approach), and execution support for IQ/OQ/PQ (or equivalent) activitiesAuthor/review key CSV deliverables as needed (e.g., URS, configuration specifications, traceability matrices, test scripts, and summary reports) and ensure alignment with SOPs and regulatory expectationsCoordinate with QA and system owners to ensure controlled change management (impact assessment, testing, approvals) for patches, upgrades, configuration changes, and integrations for GLP/GMP systemsPartner with Facilities and Manufacturing to review changes and upgrades for critical GxP systems and ensure qualification/validation considerations are embedded earlyMaintain compliant system administration practices (user access provisioning, roles/permissions, periodic access reviews) for regulated platforms in accordance with least-privilege and data integrity principlesEnsure systems are running optimally, backed up, and secured; coordinate backup/archiving solutions for regulated data in collaboration with IT End User Services and business stakeholdersWork with internal business partners, external vendors, and service providers to coordinate operational support, vendor qualification/audits as applicable, and documentation needed to maintain validated stateDevelop strategic plans and roadmaps: Creating long-term plans that align with business goals.Provide high-level data analysis and insights: Delivering actionable insights that drive business decisionsServe as a liaison between IT and business units: Facilitate communication and collaboration between IT and other departments to ensure alignmentSupport inspection readiness by ensuring validation evidence, requirements traceability, and change records are complete, current, and readily retrievable for GLP and GMP systemsEstablish and maintain best practices for data integrity (ALCOA+), storage, retention, and integrity monitoring for regulated laboratory and manufacturing dataCoordinate periodic review activities for validated systems (as required) to confirm continued fitness for intended use, validated state, and alignment with evolving regulatory expectationsTrain and support IT and business users on compliant use of qualified/validated computerized systems and related procedures (e.g., access control, change control, incident management)Perform related duties as assignedKey SkillsStrong understanding of GLP/GMP expectations for computerized systems, including 21 CFR Part 11, ALCOA+ data integrity principles, and risk‑based validation/qualification approaches aligned with GAMP 5Ability to analyze and support regulated business processes across laboratory, quality, manufacturing, or process development functions, translating regulatory and operational needs into compliant requirementsExperience supporting systems throughout the GxP lifecycle, including requirements definition, validation planning, change control, and maintenance of validated stateProven capability to influence and drive alignment across business stakeholders, and vendors without formal people‑management responsibilityStrong analytical, organizational, and time‑management skills with the ability to manage multiple priorities in regulated settingsEffective written and verbal communication skills, including creation of clear, audit‑ready documentation for both technical and non‑technical audiencesPay Range Disclosure Statement$127,000—$172,000 USDThe range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees’ and their families physical and financial health and overall well-being. These include, but are not limited to, company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program. Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. 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