Pharma

Change Lead – Learning Management System (LMS) Transformation (GxP)

We’re looking for a hands‑on Change Lead to drive the successful delivery and adoption of a new enterprise Learning Management System. In this role, you’ll turn the change strategy into practical, people‑centred activities across stakeholder engagement, communications, training readiness, and adoption support—ensuring the programme lands smoothly and delivers real business value.

You’ll work closely with Quality, Digital Enterprise Capabilities, project leadership, business stakeholders, and vendor partners to guide impacted teams through the transition and set the organisation up for long‑term success.

 

What you’ll do:

• Lead day‑to‑day change activities, aligned with key project milestones and go‑live readiness.
• Translate the change strategy into an integrated plan covering communications, engagement, learning, and adoption.
• Conduct impact and stakeholder analysis to identify risks, readiness needs, and mitigation actions.
• Build and manage stakeholder engagement plans and activate a change champion network.
• Create and deliver clear, engaging communications and end‑user materials.
• Support training planning, readiness, and learning-material quality.
• Track change actions, adoption indicators, risks, and resistance themes.
• Support governance, reporting, decision‑making, and transition to BAU.

 

What you bring:

• Experience in change management, within pharma GxP regulated environments.
• Strong communication and stakeholder management skills.
• Familiarity with GxP, IT compliance, data privacy, and validation requirements.
• Experience with LMS platforms (GxP LMS preferred).
• Ability to plan, coordinate, create content, and drive execution.
• Skilled with collaboration tools (Teams, Jira, Miro, etc.).
• Change‑management certifications (PROSCI, APMG, IOIC, etc.) are a plus.

 

Work environment:

• Fully remote, with occasional travel (Dublin/Cambridge/London).
• Some flexibility required for late‑day meetings with US West Coast stakeholders.

Location: Belgium / UK / Germany

 

I’m supporting a major biopharmaceutical company that is building out its Quantitative Clinical Pharmacology capability and looking for an experienced Pharmacometrics & AI/ML Lead. This is a strategic role for someone eager to push the boundaries of model‑informed and machine‑learning driven drug development. This position is perfect for someone who thrives at the intersection of advanced pharmacometrics, AI/ML innovation and clinical strategy. You will lead the vision and execution of AI‑enabled modelling approaches across the organisation’s development portfolio.

 

Key Responsibilities

In this role, you will drive and deliver:

• A robust AI/ML and Pharmacometrics strategy to guide dose optimisation, extrapolation, study design and regulatory planning.
• Application and evaluation of emerging technologies relevant to quantitative clinical pharmacology.
• Hands‑on delivery of AI/ML models, population PK/PD analyses, exposure–response modelling, and clinical trial simulations.
• High‑quality documentation including regulatory‑ready analysis plans and reports.
• Management of external vendors and the opportunity to internalise and grow AI/ML and PMx capabilities.
• Scientific and technical development of team members in modern PMx and AI‑driven modelling approaches.
• Engagement with global regulatory agencies, including contribution to discussions across therapy areas.
• Close collaboration with project leads to ensure seamless integration of modelling outputs.

 

We are looking for candidates with:

• PhD or MD in pharmaceutical sciences, engineering, statistics or a related field.
• 5+ years of industry experience in pharmacometrics, including significant hands-on AI/ML application in drug development.
• Strong background in population PK/PD, disease progression modelling, and simulation-based decision support.
• Technical skills in R, Python, Matlab, NONMEM or equivalent PMx software environments.

Overview:

We’re supporting a pharmaceutical manufacturing site operating in a 24/7 API / chemical processing environment. They are looking for a hands-on engineering leader to take ownership of facilities, utilities, and maintenance operations, ensuring continuous and reliable plant performance.
This is a key role focused on keeping the plant running, troubleshooting issues, and driving improvements across site infrastructure.

 

Key Responsibilities:

• Lead facilities and maintenance operations across a 24/7 manufacturing site
• Ensure reliability of critical plant utilities (e.g. HVAC, steam, water systems, compressed air, wastewater / effluent treatment)
• Act as a hands-on problem solver, supporting breakdowns and technical issues
• Drive preventive and predictive maintenance strategies to minimise downtime
• Oversee and interpret P&IDs to support troubleshooting and system improvements
• Manage and develop maintenance teams and external contractors
• Ensure site infrastructure operates in line with GMP and regulatory standards
• Support continuous improvement initiatives across plant operations

 

What They’re Looking For:

• Engineering background (Mechanical preferred)
• Strong experience in maintenance, facilities, or utilities within:
  • Pharmaceutical (API)
  • Chemical / process manufacturing
• Proven experience working in 24/7 continuous operations
• Hands-on experience with:
  • Plant utilities systems
  • Wastewater / effluent treatment (ETP/STP)
• P&IDs and process systems
• A practical, problem-solving mindset — someone who can get involved on the ground