Tech Developer-Quality Control

Job Purpose:

This role provides technical expertise around Quality Control (QC) Technologies such as CDS - Empower, Analytical Archive - NuGenesis, Lab Instrumentation including interfaces to deliver on the Quality Control Chromatography and Instrumentation Backlog which supports the QC business’s strategic direction. Specifically using Empower and NuGenesis platforms. This position is also accountable for working with our strategic suppliers to ensure service management is delivering on agreed KPIs and SLAs.

Key Responsibilities:

• Partner with the Product Owner and Product Manager(s) to develop, test, deploy & maintain technology and/or solutions to enable business value for GSK, operating within an Agile Product Model and DevOps principles.

• Responsible for the day-to-day operations within an Agile Product model, which includes but is not limited to:

  • Business process to system mapping and user requirements capture

  • Application and technology configuration & implementation e.g. automation tools

  • refining the Ux experience to ensure the most efficient experience for the user

  • Information/data flow design & implementation

  • Application integration selection/design & implementation

  • IT service to support end-to-end business processes

  • Financial evaluation e.g. Total cost of ownership calculations

• Development, maintenance and management of products and solutions, including the identification of gaps, risks and mitigation approaches.

• Engage with internal functions and external bodies (companies, standards bodies and agencies) to understand the wider ecosystem that impacts the Product area. 

• Collaborate with Portfolio & Product to ensure solutions align agreed product roadmap & feature requirements.

• Engage with key stakeholders and end users to ensure best possible User Experience (UX) and business outcomes are achieved, escalating issues as appropriate.

• Provide technical leadership in support of service delivery and lifecycle management, to optimise the Product portfolio and ensure that systems continue to operate and evolve in line with the Product Roadmap, wider Tech environment and key standards.

• Track exceptions to standards and drive their remediation.

Required Skills & Qualifications:

• BA / BSc degree in Engineering / Software / IT or relevant experience in the technical topic

• Experience in Pharma/ Biopharma QC processes (Chromatography, Lab Instrumentation)

• Experience working in a GMP regulated environment with understanding of computer validation and change control processes is highly desirable.

• Basic understanding of the science/business processes, workflows, IT tools/applications and strategic goals of the business area to which the role is aligned.

• End to End Empower and Nugenesis Configuration and Delivery.

• Lab Instrumentation interfacing and data flow.

• Instrument Driver installation and updates. Experience automating these processes is a plus.

• Good knowledge of processing, reporting issues within Empower.

• Able to configure NuGenesis SDMS templates to archive and restore data.

• Ability to effectively interact with business and IT stakeholders.

• Experience working in GxP environment.

• Proven record of maintaining inspection readiness and compliance

• Agile Delivery using Kanban or Scrum and familiarity with Agile delivery tools.

• Experience Generating and maintaining Regulated Technical documentation

• Laboratory QC Processes and experience

• Able to effectively work and communicate across global teams that cross Tech and business areas

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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