GCS D&T is working on a strategic Quality transformation, under ERP Evolution program, to implement LabWare LIMS solution for QC Processes, such as EM, Stability and QC Sample Management, while ensuring single source of truth for QC Master data, ensuring standardization and harmonization across sites / processes.
This role will lead the implementation for LabWare LIMS (from the scope definition, business requirements analysis, to implementation, validation and support in business deployment) for several key areas, including, but not limited to - Stability, Sample Management leveraging Mobile and Web-based LIMS solution, Product Specification / new interfaces.
Key Responsibilities:
Ensure the LabWare LIMS product vision, strategy, and roadmap (for Stability, Sample Management and other functional areas) aligning with GSK’s QC strategic objectives and priorities, incl. ERP Evolution program constraints.
Collaborate with stakeholders to gather and prioritize user needs, translate into product requirements, ensuring that the proposed solutions meet the needs of the users and the business as well as Tech, Security and EA (esp. for Mobile / Web solution).
Lead the design and deployment of LabWare LIMS QC Satellite Stability and Sample Management Workstreams, ensuring standardization, timely delivery and adherence to quality standards. Lead value case for any enhancements that might be required (while trying to minimize those).
Work closely with the Manufacturing and EA Tech teams to integrate e.g. QC Sample Management solutions with existing systems and in alignment with Smart Manufacturing (MES).
Together with PMO organization, develop and maintain comprehensive project plans, timelines, and budgets, ensuring all project deliverables are met within the specified constraints.
Identify potential risks and develop mitigation strategies to address any issues that may arise during the implementation of the LabWare LIMS solution.
Contribute to the creation of training and support materials for the end-users, ensuring they are proficient in utilizing the LabWare LIMS system and can effectively perform their role.
Act as a subject matter expert for LabWare LIMS, providing guidance and expertise to team members and stakeholders as needed.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Graduate in science, engineering, computing or similar level vocational qualification in technical discipline
Experience as a Product Manager in the pharmaceutical, biotechnology, or similar quality critical industry, with a focus on laboratory informatics
Understanding of laboratory workflows, processes, and technologies as well as technical skills related to IT / OT, connectivity, edge and cloud
5+ year experience with LIMS (e.g. LabWare) with the focus on QA/QC/R&D
In depth knowledge of the following process domains: - Lab Testing, Stability, Lot Release, Sample Traceability. Knowledge of Environmental Monitoring, Incoming Materials and QC Planning is a plus.
Ability to translate business use cases through to solution implementation including the informal testing and validation.
Experience in delivering complex data migrations
Experience with Agile/Scrum methodologies and tools. Knowledge of regulatory requirements and standards (e.g., Data Integrity, GxP, FDA, EMA) related to laboratory operations and informatics.
Preferred Qualifications/Experience:
If you have the following characteristics, it would be a plus:
Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
Ability to navigate organizational processes to obtain approvals
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.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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