Job description

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

Requirements

Must-haves

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
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
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)
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
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

Nice-to-haves

Bachelor’s degree (BS/BA) in Information Systems, Life Sciences, Engineering, or a related discipline, Master’s degree preferred

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