Sr. Veeva Vault Business Systems Analyst

Katalyst CRO; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Wave's Senior IT Business Analyst, GLP and GMP Systems Manager, leads business analysis and IT support for GxP computer systems across QA and RA/Reg Ops. You elicit stakeholder needs, translate to system requirements, and ensure solutions are qualified, validated, and maintained in a compliant state.

You represent IT in lifecycle activities for QMS and quality documentation, coordinating data integrity, security, and inspection readiness.

Qualifications

• Bachelor's degree in Information Systems, Life Sciences, Engineering; 8–12 years in information systems business analysis; 5+ years in GxP environments; experience with computerized system validation (CSV).
• Hands-on experience partnering with QA, RA/Reg Ops, IT, and vendors to ensure regulatory and data integrity.
• Experience supporting audits/inspections, including validation evidence, SOP alignment, and auditor inquiries related to system use and controls.

Responsibilities

• Serve as primary business analysis partner for QA and RA/Reg Ops supporting GxP systems including intake, triage, and prioritization of enhancements and defects.
• Lead requirements elicitation (workshops/interviews) and produce user stories, data flow diagrams, and configuration specs.
• Oversee mid to large-scale projects with significant business impact.
• Ensure requirements are complete, testable, and traceable through validation testing and release.
• Provide systems qualification/validation support for GLP and GMP systems and contribute to validation planning and risk assessment.
• Author/review CSV deliverables (URS, traceability matrices, test scripts) and ensure SOP alignment.
• Coordinate change management for patches, upgrades, configuration changes, and integrations.
• Maintain best practices for data integrity and ensure validation evidence is readily retrievable for GLP/GMP systems.

Skills

GxP regulatory knowledge

CSV (Computerized System Validation)

Business process analysis

Stakeholder management

Documentation & traceability

QA collaboration

Regulatory compliance

Project coordination

Education

Bachelor's degree in Information Systems, Life Sciences, Engineering

Master's degree preferred

Job description

Summary

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, RA/Reg Ops, Quality Control, Manufacturing, Process Development, and Validation.

• Serve as a primary business analysis partner for QA and RA/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 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 .
• 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.

Summary

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, RA/Reg Ops, Quality Control, Manufacturing, Process Development, and Validation.

Roles & Responsibilities

• Serve as a primary business analysis partner for QA and RA/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 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 .
• 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.

Education & 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) 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.