Digital Specialist – Analytical Development

MSI Pharma; Town of Belgium (WI); On-site; USD 80,000 - 110,000; Full time

Job summary

MSI Pharma is seeking a Digital Specialist–Analytical Development to aid in a significant digital transformation within analytical development sciences. The role requires 3–8 years of experience in data mapping and business analysis, focusing on GxP compliance and leading digital solutions. Candidates should be fluent in English and adept at stakeholder management. This freelance position is based in Wisconsin, USA, with a potential extension until December 2026.

Qualifications

• 3–8 years of professional experience.
• Proven experience in data mapping, business analysis, or data analysis.
• Strong understanding of GxP environments and ALCOA+ principles.

Responsibilities

• Act as a bridge between teams in analytical development, quality, IT, and digital.
• Analyze existing laboratory processes and data flows.
• Perform end‑to‑end process and data mapping.

Skills

Data mapping

Business analysis

GxP compliance

Stakeholder management

Fluent in English

Tools

ELN (e.g. IDBS)

LIMS (e.g. LabWare)

PowerBI

Job description

DigitalSpecialist–AnalyticalDevelopment Location: Brainel'Alleud, Belgium Engagement Status: Freelance position until end of December 2026 (strong potential extension)

Overview

We are supporting a large pharmaceutical organisation who are looking for a Digital Specialist–Analytical Development to support a major digital transformation within an Analytical Development Sciences environment, part of CMC. This role sits at the intersection of analytical laboratories, digital solutions, and regulatory compliance, supporting analytical method development and stability activities from early clinical phases through life‑cycle management. The environments span both GSP and GMP. The position is embedded in large‑scaled digital transformation program driven by FDA digital submission requirements, with a strong focus on structured, traceable, and regulatory‑ready analytical data.

Key Responsibilities

• Act as a bridge between analytical development scientists, quality, IT, and digital teams
• Analyze existing laboratory processes and data flows
• Perform end‑to‑end process and data mapping
• Translate scientific and business processes into structured data requirements
• Challenge IT and digital solutions from a business and user perspective
• Ensure compliance by design (GxP, ALCOA+)
• Support deployment of digital tools and assist end‑users
• Facilitate discussions between stakeholders and drive pragmatic, aligned solutions

Requirements

• 3–8 years of professional experience
• Proven experience in data mapping, data flow design, business analysis, or data analysis
• Strong understanding of GxP environments and ALCOA+ principles
• Experience working at the interface between business and IT
• Fluent in English (mandatory)

Hard Skills

• Translating laboratory workflows into structured digital and data requirements
• Process mapping and data flow design
• Regulatory and compliance‑driven digital solutions
• Experience with regulated environments (GxP)
• Nice to have:
• CMC, Analytical Development, or QC laboratory exposure
• ELN (e.g. IDBS), LIMS (e.g. LabWare), PowerBI
• Data governance or data engineering concepts
• Experience in digital transformation programs

Soft Skills

• Strong stakeholder management and communication skills
• Business‑oriented mindset with the ability to challenge constructively
• Ability to structure complex discussions and align diverse stakeholders
• Pragmatic, solution‑driven approach
• Comfortable working in cross‑functional, international environments