Senior IT Business Analyst – GxP Compliance & Validation

Scorpion Therapeutics; Lexington (MA); On-site; USD 140,000 - 170,000; Full time

Job summary

Wave Life Sciences seeks a Senior IT Business Analyst and Systems Manager to support GxP-regulated laboratory and manufacturing IT systems. You will drive user requirements, lead validation efforts aligned with GAMP 5, manage change controls, support audits, and maintain inspection readiness to ensure data integrity and regulatory compliance.

Onsite in Lexington, MA, you will collaborate with QA, Regulatory Affairs, Manufacturing and external vendors to strengthen system lifecycle management,

Qualifications

• 8–12 years of business analysis experience in biopharma or regulated environments.
• 5+ years supporting GLP/GMP environments.
• Strong knowledge of data integrity principles (ALCOA+) and validation.
• Experience with regulatory audits and inspection readiness.

Responsibilities

• Elicit user requirements and lead validation efforts aligned with GAMP 5.
• Manage change controls and support regulatory audits and inspections.
• Collaborate with QA, Regulatory Affairs, Manufacturing and external vendors.
• Ensure quality documentation and strong system lifecycle management and data security.

Skills

GxP systems

Validation practices

21 CFR Part 11

ALCOA+ data

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's in Information Systems

Bachelor's in Life Sciences

Bachelor's in Engineering

Tools

GAMP 5

Job description

Wave Life Sciences seeks a Senior IT Business Analyst and Systems Manager to support GxP-regulated laboratory and manufacturing IT systems. You will drive user requirements, lead validation efforts aligned with GAMP 5, manage change controls, support audits, and maintain inspection readiness to ensure data integrity and regulatory compliance.

Onsite in Lexington, MA, you will collaborate with QA, Regulatory Affairs, Manufacturing and external vendors to strengthen system lifecycle management,