Job Overview
The eBR Program Manager will lead the implementation of an Electronic Batch Record (eBR) system and Review by Exception (RBE) capability over a 2-year program.
This role requires strong leadership, technical oversight, and cross-functional collaboration to deliver a validated, integrated solution that meets business and compliance requirements.
Key Responsibilities:
* Lead the planning, execution, and delivery of the eBR/RBE implementation program across a cross-functional matrix team
* Develop and maintain comprehensive project tracking tools to ensure the timely delivery of milestones
* Facilitate requirements gathering and stakeholder alignment across Manufacturing, Quality, IT, and Engineering functions
* Define and oversee the validation approach in alignment with Quality System requirements and IT policies
* Track and report on financial performance, including spend, savings, and projected cost/benefit outcomes
* Provide regular updates to senior leadership, including the Director of Digital Transformation and Site Leadership
* Manage the engagement of internal and external resources, including third-party vendors and contractors
* Support knowledge transfer and project management best practices across the wider team
* Champion digital innovation and contribute to the site's digital transformation strategy
* Adhere to all EHS and quality standards and procedures
Qualifications & Experience:
* Bachelor's degree or higher in a relevant technical discipline (Engineering, Science, Technology); advanced qualifications are desirable
* Formal project management certification (PMP, PRINCE2) is advantageous but not essential
* Minimum 6 years' experience in manufacturing, supply chain, engineering, or process/product development within a regulated environment
* Proven track record in delivering large-scale, cross-functional programs
* Experience in managing systems validation activities and working in GMP-compliant environments
* Skilled in influencing across functional and organisational boundaries
* Strong financial acumen with experience managing budgets and ROI models
* Excellent communication, leadership, and stakeholder management skills