Digital Data & Analytics Manufacturing Execution Systems Project Leader

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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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