An IT Systems Project Manager is required to join a fantastic Cell & Gene Therapy company based in Braintree. They work with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. They are seeking a highly experienced IT Systems Project Manager with a proven track record, to assume overall management of a range of new IT business applications that are required for the organisation. The business has already identified a range of new applications to address including:
Quality Management (QMS)
Laboratory Information (LIMS)
Warehouse Management System (WMS)
There is also an internal technology strategy which has been developed by the Head of IT to which the above systems must conform. In addition, all systems must be established to comply with GAMP 5, 21 CFR Part 11 and Eudralex Vol 4 Annex 11.
On offer for the IT Systems Project Manager is a highly competitive salary and benefits package which includes an annual bonus and contributed pension.
Key responsibilities of the IT Systems Project Manager will include:
Assume overall management for the on-time delivery of the eQMS, LIMS & WMS projects
Implement a structured approach to the continuation and conclusion of the projects.
Re-baseline detailed programmes for both systems
Ensure project governance is maintained including creating and maintaining project documentation, organising project meetings and recording their minutes andactions.
Produce GANTT charts and resourcing details.
Maintain Risk Management system and risks for both systems.
Review, evaluate and mitigate potential risks in respect to the projects.
Input and advise on the status of the project and suggest any changes or improvements.
Ensure all internal stakeholders and recognised committees are updated with progress throughout the remaining duration of the project.
Manage the overall budget in conjunction with key stakeholders and ensure cost effective and best value is maintained.
Maintain adherence to IT Strategy.
Provide regular and detailed reports as required.
Ensure transparency of the overall process to all stakeholders.
Manage change control and strictly adhere to agreed process.
Create and deliver project work plans and revise as appropriate to meet changing needs and requirements.
Performs other duties as and when directed.
Educated to Degree level or equivalent experience.
Prince 2 or Agile methodology qualified (desirable)
GAMP 5 & Annex 11 understanding and experience. Must also be familiar with the MHRA requirements concerning validated systems data integrity.
Pharmaceutical or biopharmaceutical experience preferred.
Experience of pharma industry and IT validation essential.
Previous experience of similar scale system implementations
Prince 2, Agile or similar structured approach to projects and change management
MS Office I MS Project experience (experience of SAP would be of benefit)
Seniority and gravitas to assume control of the current live status of the project and excellent communications and presentation skills to report to colleagues and industry leaders.
Excellent communication skills directed at establishing and maintaining collegial and collaborative relationships with project stakeholders.
Strategic thinker with experience of influencing clients and providing improvements.
Knowledge and experience of OJEU and ITT / Tender process
Budgeting and cost control skills/ experience
Ability to prioritise and clearly define and explain needs.
Familiar with risk management processes
Knowledge and personal skills to be the successful candidate:
Able to evaluate complex situations and find solutions for them in a professional manner.
Project ownership and pride in its delivery
Having a passion for delivering excellent customer service in a cost effective way
Flexibility towards work assignments and new learning
Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
Comfortable operating autonomously once goals and objectives are set.
Excellent interpersonal, written and verbal communication skills.
Having current and up to date professional knowledge, expertise and best practice.
Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
Ability to quickly establish credibility and build rapport and trust.
A good team player, with strong organisational skills