Senior GxP IT Business Analyst — GLP/GMP & Validation

Planet Pharma; Lexington (MA); On-site; USD 130,000 - 170,000; Full time

Job summary

Planet Pharma in Lexington, MA seeks a Senior IT Business Analyst, GLP/GMP Systems Manager to support Wave’s GxP computerized systems. You’ll partner with QA and Regulatory Affairs to elicit needs, write clear system requirements, and ensure validation and compliance throughout the lifecycle.

Onsite up to five days per week, you will drive disciplined change control, data integrity, and inspection readiness, leveraging CSV/CSA practices and GAMP5 guidance to sustain validated state across

Qualifications

• Bachelor’s degree in IS, life sciences, or engineering; Master’s preferred.
• 8–12 years in information systems business analysis.
• 5+ years in GLP/GMP environments with validation governance.
• Hands-on CSV and CSA activities in GxP settings.
• Translate regulatory needs into compliant system requirements.

Responsibilities

• Partner with QA and Reg Ops to support GxP systems (QMS, docs, tools).
• Lead requirements elicitation and produce user stories and maps.
• Manage large projects with significant business impact.
• Ensure complete validation through IQ/OQ/PQ activities.
• Coordinate change management for patches, upgrades, integrations.
• Maintain data integrity and regulatory-aligned data handling.

Skills

GxP knowledge

Regulatory compliance

Business analysis

Requirements elicitation

Stakeholder collaboration

Education

Bachelor’s degree in Information Systems / Life Sciences / Engineering

Master’s degree preferred

Tools

CSV validation

CSA / validation governance

GAMP 5 framework

Job description

Planet Pharma in Lexington, MA seeks a Senior IT Business Analyst, GLP/GMP Systems Manager to support Wave’s GxP computerized systems. You’ll partner with QA and Regulatory Affairs to elicit needs, write clear system requirements, and ensure validation and compliance throughout the lifecycle.

Onsite up to five days per week, you will drive disciplined change control, data integrity, and inspection readiness, leveraging CSV/CSA practices and GAMP5 guidance to sustain validated state across