eBR Program Manager

The Role:

• eBR Program Manager
  


• Onsite Role


• Mayo


• Contractor Opportunity

Role Brief:

This role will involve providing technical support and leadership to the cross functional team of a key NNIT client. The team is responsible for a project focused on the implementation of electronic batch record (eBR) and review by exception (RBE). The project is expected to take circa 2 years.

The eBR Program Manager will lead the Change Management activity including cross functional requirements gathering, business process design and architecture, system validation, and consensus building towards an end to end, integrated systems environment which meets all required standards and regulations.

The role does not have direct reports but will manage multiple cross functional resources including external contractors.

Key Responsibilities:

• Develop and manage a detailed project plan for all aspects of the program.


• Evaluate activities, timelines and resource requirements necessary for the development and deployment of eBR/RBE.


• Develop and maintain detailed program tracking tools and hold cross-functional matrix team to account for delivery of milestones across the 2 year program.


• Ensure compliance with all necessary Quality and IT policies and procedures.


• Define and document the systems validation process with input and agreement from the Global systems owners.


• Track the Financial costs of the program and associated savings.


• Provide timely and accurate updates to Director Digital Transformation, Site Leadership Team and ME&C management regarding project planning and execution.

Skills Brief:

• Strong Project Management experience (5+ years) in Pharma, Life Sciences, Biotech, Medical Devices manufacturing is essential - candidates without this experience will not be considered.


• Experience in or a strong understanding of the implementation of eBR/RBE is also essential


• Verifiable experience in planning and executing projects in manufacturing, supply chain management, engineering, process or product development in the Pharma, Life Sciences, Biotech, Medical Devices is required


• Experience in leading cross-functional teams.


• Experience in influencing peers in other organizations and senior management.

Person Brief:

The ideal individual will combine the right mix of academic qualifications with strong hands on projects management experience in the Pharma, Life Sciences, Biotech, Medical Devices manufacturing sector.

You will have a minimum of a Level 8 or equivalent  Bachelors Degree in a relevant field such as Engineering, Science or Technology and ideally you will have a recognized Project Management qualification (the PM qualification is not essential if you have the right experience. A minimum of 5 years relevant PM experience is essential.

The role is designated as onsite and while some hybrid working may be possible, the role will be mostly onsite in Mayo and therefore you must be able to be onsite daily as required and therefore living within a reasonable commute and have your own transport.

Opportunity Brief:

This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. NNIT offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.

Company Brief:

NNIT is a publicly listed company that specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT employs more than 1,800 people in Europe, Asia, and USA.