Senior IT Business Analyst, GLP & GMP

Wave Life Sciences; Lexington (MA); On-site; USD 127,000 - 172,000; Full time

Job summary

Wave Life Sciences in Lexington, MA is seeking a Senior IT Business Analyst to support GLP/GMP systems and QA/regulatory operations. You will elicit user needs, translate them into clear requirements, and ensure qualified, validated solutions remain compliant across QMS and related tools.

You will partner with QA,Reg Ops, and IT to drive validation planning, risk assessments, and inspection readiness, including CSV artifacts and change control. Onsite work up to five days/week is expected.

Qualifications

• Bachelor's degree in Information Systems, Life Sciences, Engineering or related field; Master’s preferred.
• 8-12 years of information systems business analysis experience.
• 5+ years supporting GxP-regulated environments with emphasis on validation and inspection readiness.
• Hands-on CSV/CSA activities including requirements, risk assessments, validation planning, testing, and change control.
• Experience translating regulatory and operational needs into compliant system requirements.
• Ability to partner with QA, IT, and external vendors to meet regulatory/data integrity expectations.

Responsibilities

• Serve as primary business analysis partner for QA and Reg Ops on GxP systems (QMS, quality documentation, submissions tools).
• Lead requirements elicitation (workshops/interviews) and produce user stories, process maps, data flows, and specs.
• Oversee mid-to-large projects with significant business impact.
• Collaborate with QA/Validation to ensure testability and traceability through lifecycle.
• Provide CSV qualification/validation support for GLP and GMP systems (IQ/OQ/PQ).
• Create and review CSV deliverables (URS, specs, traceability matrices, test scripts).
• Coordinate change management for patches, upgrades, and integrations.
• Ensure data integrity, access control, and regulatory alignment across systems.
• Train users and support inspection readiness with audit-ready documentation.
• Develop strategic roadmaps aligning IT with business goals.

Skills

GxP experience

CSV validation

QA collaboration

Regulatory compliance

Requirements elicitation

Data integrity

Audit readiness

Process analysis

SOP alignment

Education

BS/BA in Information Systems, Life Sciences, Engineering

Master’s degree preferred

Tools

QMS software

Document management systems

Job description

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.

Description

The 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.

Experience

• Bachelor’s degree (BS/BA) in Information Systems, Life Sciences, Engineering, or a related discipline, Master’s degree preferred
• 8-12 years of experience in Information systems business analysis
• 5+ years of experience supporting GxP‑regulated (GLP/GMP) environments, with demonstrated focus on compliance, validation governance, and inspection readiness
• Hands‑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 procedures
• Proven 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 requirements
• Experience partnering closely with Quality Assurance, business SMEs, IT, and vendors to ensure systems and processes meet regulatory and data integrity expectations
• Experience supporting audits and inspections, including preparation of validation evidence, SOP alignment, and response to auditor inquiries related to system use and controls

Responsibilities

• Serve 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 needs
• Lead 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 practices
• Oversee mid to large‑scale projects: Managing projects with significant business impact
• Partner 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) activities
• Author/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 expectations
• Coordinate with QA and system owners to ensure controlled change management (impact assessment, testing, approvals) for patches, upgrades, configuration changes, and integrations for GLP/GMP systems
• Partner with Facilities and Manufacturing to review changes and upgrades for critical GxP systems and ensure qualification/validation considerations are embedded early
• Maintain compliant system administration practices (user access provisioning, roles/permissions, periodic access reviews) for regulated platforms in accordance with least‑privilege and data integrity principles
• Ensure systems are running optimally, backed up, and secured; coordinate backup/archiving solutions for regulated data in collaboration with IT End User Services and business stakeholders
• Work with internal business partners, external vendors, and service providers to coordinate operational support, vendor qualification/audits as applicable, and documentation needed to maintain validated state
• Develop 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 decisions
• Serve as a liaison between IT and business units: Facilitate communication and collaboration between IT and other departments to ensure alignment
• Support inspection readiness by ensuring validation evidence, requirements traceability, and change records are complete, current, and readily retrievable for GLP and GMP systems
• Establish and maintain best practices for data integrity (ALCOA+), storage, retention, and integrity monitoring for regulated laboratory and manufacturing data
• Coordinate periodic review activities for validated systems (as required) to confirm continued fitness for intended use, validated state, and alignment with evolving regulatory expectations
• Train 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 assigned

Key Skills

• Strong 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 5
• Ability to analyze and support regulated business processes across laboratory, quality, manufacturing, or process development functions, translating regulatory and operational needs into compliant requirements
• Experience supporting systems throughout the GxP lifecycle, including requirements definition, validation planning, change control, and maintenance of validated state
• Proven capability to influence and drive alignment across business stakeholders, and vendors without formal people‑management responsibility
• Strong analytical, organizational, and time‑management skills with the ability to manage multiple priorities in regulated settings
• Effective written and verbal communication skills, including creation of clear, audit‑ready documentation for both technical and non‑technical audiences

Pay Range Disclosure Statement: $127,000 USD - $172,000 USD

The 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. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.