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. Operating in a complex manufacturing environment, 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:
1. Lead the planning, execution, and delivery of the eBR/RBE implementation program across a cross-functional matrix team
2. Develop and maintain comprehensive project tracking tools to ensure the timely delivery of milestones
3. Facilitate requirements gathering and stakeholder alignment across Manufacturing, Quality, IT, and Engineering functions
4. Define and oversee the validation approach in alignment with Quality System requirements and IT policies
5. Track and report on financial performance, including spend, savings, and projected cost/benefit outcomes
6. Provide regular updates to senior leadership, including the Director of Digital Transformation and Site Leadership
7. Manage the engagement of internal and external resources, including third-party vendors and contractors
8. Support knowledge transfer and project management best practices across the wider team
9. Champion digital innovation and contribute to the site's digital transformation strategy
10. Adhere to all EHS and quality standards and procedures
Qualifications & Experience:
11. Bachelor's degree or higher in a relevant technical discipline (., Engineering, Science, Technology); advanced qualifications are desirable
12. Formal project management certification (., PMP, PRINCE2) is advantageous but not essential
13. Minimum 6 years' experience in manufacturing, supply chain, engineering, or process/product development within a regulated environment
14. Proven track record in delivering large-scale, cross-functional programs
15. Experience in managing systems validation activities and working in GMP-compliant environments
16. Skilled in influencing across functional and organisational boundaries
17. Strong financial acumen with experience managing budgets and ROI models
18. Excellent communication, leadership, and stakeholder management skills