Job Title:
Electronic Batch Record Program Leader
Overview:
The Electronic Batch Record (eBR) program leader will oversee the implementation of a validated, integrated eBR system and Review by Exception (RBE) capability within a complex manufacturing environment. This is a 2-year program that requires strong leadership and project management skills.
Responsibilities:
* Lead 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 timely delivery of milestones.
* Facilitate requirements gathering and stakeholder alignment across Manufacturing, Quality, IT, and Engineering functions.
* Define and oversee validation approach in alignment with Quality System requirements and IT policies.
* Track and report on financial performance, including spend and projected cost/benefit outcomes.
* Provide regular updates to senior leadership, including Director of Digital Transformation and Site Leadership.
* Manage engagement of internal and external resources, including third-party vendors and contractors.
* Support knowledge transfer and project management best practices across wider team.
* Champion digital innovation and contribute to site's digital transformation strategy.
Requirements:
* Bachelor's degree or higher in relevant technical discipline; advanced qualifications desirable.
* Formal project management certification advantageous but not essential.
* Minimum 6 years' experience in manufacturing, supply chain, engineering, or process/product development within 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.
Skills:
* Project management.
* Leadership.
* Stakeholder management.
* Financial management.
* Communication.
Qualifications:
BA/BS degree or higher in a related field.