Senior IT Business Analyst, GLP & GMP

Reference: 631898

Posted:

Location:

Lexington, Massachusetts Company:
Planet Pharma Group Contact:
Applications Email: applications

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 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 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…