Job Description

The Digital Data & Analytics Manufacturing Execution Systems Project Leader will deploy MES systems as well as manage and maintain existing GSC Zebulon Manufacturing Execution Systems (MES), i.e. Electronic Batch Records, to support the business continuity and delivery of the company’s ‘Digital and Smart Manufacturing’ ambition. 

This role is directly involved in the delivery of the GSC Smart Manufacturing business imperative, using technology, data, and systems to transform the way we manufacture and supply, creating a reliable, resilient and agile supply chain, with a view to being an industry leading in smart manufacturing by 2030.

Deploy technical solutions across quality, manufacturing, maintenance and logistics operations, improving efficiency and reducing waste by identify opportunities, implement solutions and manage/improve those processes through modern/agile best practices.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. 

These responsibilities include some of the following:

Partner with GSK central functions and local departments, including GPS, PROD, ENG, MSAT and Finance to ensure alignment, prioritization and support of site DDA and Smart Automation programs
Lead the Deployment of MES Solutions across site by developing technical/business requirements, updating associated documentation, hardware installations, managing change control, leading validation testing, and conducting user training and cutover activities.
Build relationships with each function and global stakeholders to establish a robust communication process for effective delivery of requests and develop processes to efficiently implement changes into Production
Setup and facilitate a change forum to work with GPS, Production, MSAT, Quality, and Site IT to identify and implement continuous improvement
Manage deviations which cite MES systems as contributory cause or solution and attend CAPA selection sessions to support robust CAPA and highlight potential ineffective CAPA
Provide clear and effective communication of project to stakeholder, sound delivery of solutions that are on time and delivers business benefit.
Represent the MES team in Regulatory Inspections of systems
Maintain budgetary control - monitor and respond to risks / issues at the project and program level to ensure on time and in budget delivery

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

5+ years of experience in pharmaceutical industry
Experience in Incident management, Problem Solving and Change Management
Experience of Project Management of Technical Projects
Experience of systems/software development methodologies
Experience in a manufacturing environment
Experience with application design, testing and deployment of digital solutions in a GxP environment.
Experience with Data Integrity principals
Experience with Validated Computer Systems

Preferred Qualifications:

Bachelor’s degree in Mathematics, Engineering, Computer Science or technical discipline
Business Process and Workflow Design, Document Mgmt, Experience in system software development methodologies
Is familiar with the concepts, standards, technology, tools,
processes, procedures, hardware, software and services in use for delivering technical solutions
Knowledge in Agile, Azure SQL, and Azure Data Lakes; Microsoft Power Platforms, Data Science
Knowledge and experience working with Six Sigma/Lean Sigma processes and tools.
Knowledge and experience supporting GxP and Sarbanes
Oxley regulated applications
Comprehensive knowledge and understanding of the Systems Development Life Cycle
Good knowledge and understanding of IT systems and how they apply to supported business areas.
Knowledge of systems/software development methodologies and system architectures
High learning agility - ability to learn and adapt to new concepts, systems, and software independently and quickly
Well-developed analytical and problem-solving skills
Strong relationship building and team working skills to influence and drive Business change
Must be able to work independently with minimal supervision
Experience at working within a cross functional team with proven collaboration, influencing and leadership skills
Full understanding of Good Manufacturing Practice in a Pharmaceutical Environment and EHS standards
Evidence of leading improvement activities with delivery of quantifiable business improvement
Expert competency in project work
Formal root causing and problem-solving techniques
Confident in own ability. Makes timely decisions in a confident way with justification if necessary. Ensures others are very clear about own stance or position when uncertainty exists
Ability to present technical concepts to end users as well as Senior level managers.