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:
- 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 (e.g., Engineering, Science, Technology); advanced qualifications are desirable
- Formal project management certification (e.g., 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
For a confidential discussion and more information on the role, please contact Kevin Griffin.
kevin.griffin@collinsmcnicholas.ie
(021) 2427108