GxP IT Business Analyst: GLP/GMP & QA Systems Lead

Wave Life Sciences; Boston (MA); On-site; USD 127,000 - 172,000; Full time

Benefits offered by this job

500-800 Health insurance

401K participation with matching contributions

Employee Stock Purchase Program

Job summary

Wave Life Sciences is seeking a Senior IT Business Analyst, located in Lexington, MA, to support GLP/GMP systems. This role focuses on business analysis and IT systems for quality assurance and regulatory affairs, ensuring compliance and data integrity within a GxP environment.

The position involves eliciting user needs, managing validation projects, and overseeing system lifecycle activities. Candidates should have a strong understanding of regulatory requirements and experience with computerized system validation.

Qualifications

• 3-5 years of experience in information systems business analysis.
• Hands-on experience with computerized system validation (CSV) and Computer Systems Assurance (CSA).
• Experience supporting audits and inspections.

Responsibilities

• Serve as a primary business analysis partner for QA and Regulatory Affairs teams.
• Lead requirements elicitation activities and produce fit-for-purpose deliverables.
• Oversee projects with significant business impact.

Skills

GxP compliance knowledge

Analytical skills

Project management

Communication skills

Education

Bachelor’s degree in Information Systems, Life Sciences, Engineering or related

Tools

Computerized system validation tools

Job description

Wave Life Sciences is seeking a Senior IT Business Analyst, located in Lexington, MA, to support GLP/GMP systems. This role focuses on business analysis and IT systems for quality assurance and regulatory affairs, ensuring compliance and data integrity within a GxP environment.

The position involves eliciting user needs, managing validation projects, and overseeing system lifecycle activities. Candidates should have a strong understanding of regulatory requirements and experience with computerized system validation.