Senior IT Business Analyst

EPM Scientific; Boston (MA); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

EPM Scientific, a partner to a clinical-stage biotechnology company, seeks a Senior IT Business Analyst to partner with Quality, Regulatory, Manufacturing, and Lab Operations across GxP systems.

You will lead requirements, support CSV/CSA efforts, ensure inspection readiness, and drive cross-functional initiatives with IT leadership and external vendors.

Qualifikationen

• Bachelor’s degree in a relevant field.
• 8+ years of regulated life sciences BA/IT experience.
• Experience with CSV/CSA, GxP systems, and change control.
• Knowledge of 21 CFR Part 11 and data integrity concepts.

Aufgaben

• Liaise IT with Quality/Regulatory stakeholders for GxP systems lifecycle.
• Lead requirements gathering, process analysis, and documentation.
• Support validation efforts, risk assessments, test planning, traceability, and change control.
• Coordinate with vendors and internal teams on technology initiatives.

Kenntnisse

GxP systems

CSV/CSA

Regulatory compliance

Requirements gathering

Stakeholder collaboration

21 CFR Part 11 knowledge

Ausbildung

Bachelor's degree in Information Systems, Life Sciences, Engineering

Tools

GAMP 5

ALCOA+

21 CFR Part 11

Jobbeschreibung

Role: Senior IT Business Analyst, GxP Systems

EPM is partnered with a clinical-stage biotechnology company developing next-generation genetic medicines for serious diseases. Leveraging a proprietary RNA-based platform, the organization is advancing multiple clinical and preclinical programs while continuing to build the quality, regulatory, and technology infrastructure needed to support future growth. As the company expands its regulated systems environment, they are seeking a Senior IT Business Analyst to partner closely with Quality, Regulatory, Manufacturing, and Laboratory Operations teams across critical GxP systems.

Responsibilities:

• Serve as the primary liaison between IT and Quality/Regulatory stakeholders, supporting the lifecycle management of regulated GxP systems.
• Lead requirements gathering, business process analysis, and documentation activities to support system enhancements, implementations, and compliance initiatives.
• Support computerized system validation (CSV/CSA) efforts, including requirements, risk assessments, test planning, traceability, and change control activities.
• Partner with Quality, Manufacturing, and Laboratory teams to ensure systems remain compliant, validated, secure, and inspection-ready.
• Lead cross-functional projects and coordinate with internal stakeholders and external vendors to support strategic technology initiatives.

Qualifications:

• Bachelor's degree in Information Systems, Life Sciences, Engineering, or a related field.
• 8+ years of Business Analyst, IT Systems, or related experience within regulated life sciences environments.
• Strong experience supporting GxP-regulated systems, including GLP/GMP environments.
• Hands-on experience with Computerized System Validation (CSV), Computer System Assurance (CSA), GAMP 5, and change control processes.Working knowledge of 21 CFR Part 11, data integrity principles (ALCOA+), and regulatory inspection readiness requirements.
• Competitive base salary, annual bonus, and long-term incentive opportunities.
• Comprehensive medical, dental, and vision coverage.
• High-visibility role partnering with Quality, Regulatory, Manufacturing, and IT leadership teams.
• Opportunity to support cutting-edge biotechnology programs while helping shape the organization's regulated systems strategy and compliance infrastructure.