Digital Business Lead in Harlow

The business lead for the Electronic Batch Record (eBR) system is accountable for the global business strategy, roadmap, and lifecycle of a cGMP computerized system that supports pharmaceutical manufacturing and quality processes. In this role, you define and lead the global product vision from a business perspective, ensuring CBR remains fit for intended GxP use, compliant with data integrity requirements, and aligned with global process and quality standards across departments and sites. You will steer a network of Local Business Owners (LBOs) and cross‑functional stakeholders (Tech, QA, SMEs) to translate business needs into robust user requirements, test strategies, and releases that deliver value to operations. The position offers the opportunity to influence global ways of working, drive harmonization across sites, and develop your leadership profile through ownership of roadmap, audits, deviations, and continuous improvement initiatives.

Responsibilities

• Define and lead the business roadmap for eBR across divisions ensuring the system is aligned with process requirements, sites deployment and fit for intended use in cGMP environments.
• Create, prioritize and maintain User Requirements in collaboration with LBOs, SMEs (Subject Matter Expert), Tech, QA (Quality Assurance); Create and maintain global business documentation (e.g., RSD, global SOPs (Standard Operating Procedure), eCC (electronic Change Control).
• Oversee global business test activities (including dry‑runs, E2E scenarios, and business test cases), is accountable for validation and global auto-Inspection.
• Define the global training strategy for eBR and related business processes, develop and maintain global training materials, build and lead a network of LBOs and key stakeholders, and proactively communicate upcoming changes, releases, and their process, documentation, training, and reporting impacts to ensure consistent understanding and adoption across sites.
• Ensure data generated and maintained in eBR is compliant and controlled, fit for purpose for regulatory submissions, overseeing data integrity risk identification and mitigation, supporting sites during audits and inspections, and providing global oversight that the system and processes remain compliant and fit for purpose.
• Own system‑related global deviations and associated CAPAs (Corrective and Preventive Action), provide second‑line business support and trend oversight.
• Participate in transverse forums on cross‑system impacts and drive continuous improvement and harmonization opportunities across the network.
• Partner closely with Tech (Product Management, Technical Product Owner, development, validation) and QA (Global and Local) to align on priorities, risk and compliance expectations, validation strategies, and incident/deviation outcomes throughout the system lifecycle.
• Some international travel may be required (up to 10%).

Basic Qualifications

• Bachelor's degree in engineering, life sciences, computer sciences or related technical discipline.
• Minimum 6 years of experience in pharmaceutical manufacturing (vaccines, biopharmaceuticals, small molecules) or manufacturing execution systems (vaccines, biopharmaceuticals, small molecules).
• Experience in eBR, Mendix/low‑code application development platforms.
• Experience working in cGMP‑regulated environments, including regulatory requirements and data integrity practices.
• Experience in solution development, testing, validation, implementation.
• Experience in project management and delivery.
• Experience conducting troubleshooting, problem analysis, and risk assessments.
• Written and verbal communication in English required and French will be an added advantage.

Preferred Qualifications

• Ph.D. in a technical discipline (engineering, life sciences, computer sciences, etc.) or M.S. in these disciplines with relevant experience in one of the following areas: Manufacturing execution systems used in pharmaceutical manufacturing (vaccines, biopharmaceuticals, small molecules, etc.) Lab/pilot/commercial scale pharmaceutical manufacturing (vaccines, biopharmaceuticals, small molecules, etc.) Knowledge in multiple areas within pharmaceutical process development, technology transfer, scale‑up, process engineering, and/or cGMP batch execution, including experience across multiple functions or modalities (vaccines, biopharmaceuticals, sterile manufacturing, ADCs, oligonucleotides, small molecules).
• Possesses excellent troubleshooting/problem analysis/risk assessment skills, including experience with Lean Sigma and Root Cause Analysis methodologies.

Work Arrangements

This is a hybrid role based in Wavre, Belgium with 2 days of onsite presence required with close collaboration across functions.

Skills

• Biopharmaceuticals
• Bioprocessing
• Cell Line Development
• Drug Development
• Experimental Methods
• Molecular Cell Biology
• Pharmaceutical Industry
• Pharmaceutical Manufacturing
• Quality by Design
• Regulatory Submissions
• Simulation Models
• Technical Writing
• Technology Transfer

Salary Range

The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.