Program Director
The eBR Program Director will oversee 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:
* Oversight of the planning, execution, and delivery of the eBR/RBE implementation program across a cross-functional matrix team
* Development and maintenance of comprehensive project tracking tools to ensure timely delivery of milestones
* Facilitation of requirements gathering and stakeholder alignment across Manufacturing, Quality, IT, and Engineering functions
* Definition and oversight of the validation approach in alignment with Quality System requirements and IT policies
* Tracking and reporting on financial performance, including spend and projected cost/benefit outcomes
* Regular updates to senior leadership, including the Director of Digital Transformation and Site Leadership
* Management of the engagement of internal and external resources, including third-party vendors and contractors
* Support for knowledge transfer and project management best practices across the wider team
* Championing digital innovation and contributing to the site's digital transformation strategy
* Adherence to all EHS and quality standards and procedures
Qualifications & Experience:
* Bachelor's degree or higher in a relevant technical discipline; advanced qualifications are desirable
* Formal project management certification 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
This position requires a strategic leader who can effectively collaborate with cross-functional teams to deliver a validated eBR system and RBE capability. The ideal candidate will have a proven track record in delivering large-scale programs and experience in managing systems validation activities in a GMP-compliant environment.
The eBR Program Director will be responsible for overseeing the planning, execution, and delivery of the eBR/RBE implementation program. This includes developing and maintaining comprehensive project tracking tools, facilitating requirements gathering and stakeholder alignment, and defining and overseeing the validation approach.
In addition to these key responsibilities, the eBR Program Director will provide regular updates to senior leadership, manage the engagement of internal and external resources, and support knowledge transfer and project management best practices across the wider team.
This is an excellent opportunity for a seasoned program director to join our organisation and contribute to the site's digital transformation strategy. If you are a strategic leader with a proven track record in delivering large-scale programs, we encourage you to apply for this exciting opportunity.