Business Analyst — GxP Signals Electronic Notebook (Synthetics Development)

Location: Beerse, 1 day a week onsite

Key Responsibilities:

• Serve as the primary liaison between synthetics scientists, lab operations, IT/development, and quality teams to translate user needs into clear, testable requirements for GxP-compliant changes.

• Lead user engagement activities such as interviews, workshops, shadowing, surveys, and user acceptance testing (UAT) to identify pain points and improvement opportunities.
• Define functional specifications, user stories, acceptance criteria, and process flows for new features or configuration changes.
• Support GxP lifecycle activities including validation planning, traceability, execution of test scripts, documentation for change control, and generation of UAT evidence.
• Prioritize enhancements with stakeholders, balancing regulatory, scientific, and operational impact; manage a backlog and roadmap for incremental releases.
• Coordinate onboarding of teams currently out of scope, including requirements gathering, configuration, training materials, and go-live support.
• Re-engage already deployed teams to collect feedback, drive small-batch improvements, and measure adoption metrics.
• Facilitate cross-functional decision-making and provide regular status updates to project and quality leadership.

Required Qualifications and Experience:

• Specific experience with ELN is a must.

• Proven experience in business analysis, particularly in GxP environments.
• Strong communication skills in English.
• Ability to work collaboratively with cross-functional teams.
• Experience in user engagement and requirements gathering.
• Familiarity with validation planning and change control documentation.

Desired Skills and Certifications:

• Experience in synthetics development or similar scientific fields.

• Proficiency in creating user stories and process flows.
• Knowledge of regulatory requirements and compliance standards.