Job Purpose:
The Senior Manager QC systems LES is a key person in the global management of the LES system that is used by QC laboratories within the GSK Global Supply Chain. This role belongs to the Global LES BAU Operations team that is responsible for the operational business as usual support of the LES application and reports directly to the ‘QC Systems BAU Senior Operations Associate Director’.
The responsibilities of this role include providing lead support for the following:
The lifecycle of the LES static data
The lifecycle of the LES application (annual review, validation, upgrade, documentation, …).
Ticket (issue) management
General site support including assisting users with how to use the system.
LES: Laboratory Execution System
BAU: Business as usual
Key Responsibilities:
Global Static Data Lifecycle Support:
Support the end to end life cycle management of static data change requests, working closely with sites and Tech to ensure changes meet Operational Level Agreement delivery timeframes at least 90% of the time and satisfy quality and regulatory requirements.
Perform and support the triage, prioritization, complexity assessment and grouping of static data change requests. This requires an understanding of the complex interdependencies that can exist between static data requests and their impact on the static data and validation process. Decisions with justifications will be required to support the approval/rejection of requests or escalation to the LES Change Approval Board.
Work with the sites to define the required information to deliver the medium to complex static data requests. This involves understanding the site analytical procedures/business processes and which supporting documents are required (i.e. SOP’s, analytical methods, product specifications), requesting and obtaining these documents from the site and then translating the documents into static data requirements.
Define other QC System requirements (e.g. M-ERP data extracts, Empower mapping and simple/complex instrument output) to ensure they align with the relevant data strategy. This requires understanding of the complex interfaces between LES and other QC systems.
Review LES static data requirements and other validation documentation (i.e. change control documentation) to ensure they have been completed correctly and align with the relevant laboratory application data strategy and Analytical Data Governance standards. It is a responsibility of this role to decide that the static data request is ready to transfer to the Tech teams.
Review validation documentation (i.e. change control documentation) to ensure they have been completed correctly and align with the relevant quality procedures.
Regularly monitor the compliance to data standards of new and existing static data. This requires the identification of new reference data or standards, participation in Analytical Data Governance boards for approval of new standards/reference data and then ensuring compliance to these standards.
Perform and support the business in conducting demo or dry runs, providing clear feedback to static data configuration teams. It is a responsibility of this role to decide that the static data configuration meets the requirements satisifactorily and is ready for informal/formal verification.
Perform and support the definition and execution of informal and formal verification of medium/complex static data change requests. Assist with defect investigations and resolution. This requires understanding the site business processes and technical use of the LES system. It is a responsibility of this role to decide that the static data configuration can go live in Production.
End User Support:
Participate in the investigation and resolution of Level 3 tickets from a quality and business perspective. This requires an understanding of site business processes and the design and correct use of the LES system.
Support identification, root cause analysis, impact assessment and CAPA definition for QC System related deviations and incidents in collaboration with key stakeholders. This requires an understanding of site business processes and the design and correct use of the LES system.
Direct users to follow standard processes and assist users with the correct use of the system.
General Support
Ensure annual user reviews and other compliance related activities are completed on time
Identify and perform continuous improvement of BAU procedures and documentation as required to improve the efficiency and performance of the LES BAU team.
Prepare BAU KPI reports for senior management.
Knowledge/ Education / Experience Required:
Education: Degree or certification in scientific discipline
Experience: Min. 10 years of experience working in a GMP Laboratory
Other Job Related skills:
Labware Electronic Laboratory Notebook knowledge
Strong technical ability with Tech tools, management of databases used in regulated environment (eg. Advanced usage of SQL developer, SAP processes, …)
Knowledge of GMP regulated environment, laboratory testing, Pharmacopeia is an advantage
Knowledge in Computer System Validation documentation / SOP/process writing experience
Learning agility: able to learn new processes quickly and anticipate consequence of changes on end-to-end flow
Organized, Structured, Rigorous, Reliable and Detail Oriented Competences:
Affinity with Tech tools (Excel, SAP, LIMS, ELN)
Meticulous, proactive, autonomous
Highly organized and able to manage multiple tasks
Ability to adapt to short term priority changes
Curious, eager to learn
Creative approach to problem solving
Team player, good listening and communication skills
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