Senior IT Business Analyst, GLP & GMP

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

Role

Senior IT Business Analyst and Systems Manager supporting GxP-regulated laboratory and manufacturing systems within Wave Life Sciences' biopharma environment. Objectives include ensuring compliance, data integrity, and validation of computerized systems supporting quality and regulatory functions.

Responsibilities

• eliciting user requirements, leading validation efforts aligned with GAMP 5, managing change controls, supporting audits, and maintaining inspection readiness.
• involved close collaboration with QA, Regulatory Affairs, Manufacturing, and external vendors, with a focus on quality documentation, system lifecycle management, and data security.

Requirements

• Bachelor’s in Information Systems, Life Sciences, Engineering, or related; 8-12 years’ experience in business analysis and 5+ years supporting GLP/GMP environments;
• strong knowledge of 21 CFR Part 11, ALCOA+ data principles, and validation practices.

Preferred

• Master’s degree, prior validation experience with laboratory and manufacturing IT systems, and ability to influence cross-functional teams.

HighValue

• supporting regulated systems throughout their lifecycle, validation and compliance expertise, GxP systems in biotech, handling audits and inspection readiness, focus on data integrity, and collaboration with QA and regulatory teams.

WorkSetup

Onsite in Lexington, MA, with up to five days per week presence.