Talent jobs in United Kingdom

The External Quality (EQ) Systems Lead supports External Quality to transform how we work by continuous improvement, standardisation and user support of key systems that drive the core processes within EQ and the GSC division. This role works closely with groups within EM/Procurement and GSK sites and stakeholders as a conduit of information flow from external parties, CMO and/ or suppliers, to ensure systems and standard processes are in place and in use in a compliant and robust manner.

1. Individuals in this role may be responsible for maintaining key areas of compliance: This may include areas such as QMS, Quality digital data systems & initiatives – including metrics & scorecards/dashboards, data mapping, Quality Alerts, QRI, Risk Modelling, Data Analysis & Management, Deviation/Complaint/Change/CAPA Management, Audit & Inspections, Regulatory Conformance, Documentation, etc.

2. Provide operational advice/guidance/advocacy of these focus systems and maintain the related programmes of governance, escalation, consultation, communication and training

3. Ensure that GMP records are effectively managed, tracked and reported. This may involve direct use of systems, or indirect use supporting colleagues using them. This will include internal GSK processes, as well as those which support the GMP of products and materials with our external manufacturers and suppliers.

4. Ensure Quality Systems are maintained & governed with appropriate Quality and data integrity requirements

5. Suggest and support improvements implementation to processes and systems – including simplification, standardisation, knowledge management and sharing

6. Provide support to EQ and related functions (such as EM/Procurement/etc) in the monitoring and analysis of Quality performance using appropriate KPIs/metrics/trackers and reporting to provide visibility to stakeholders of status and look-ahead and flagging emerging issues or trends

7. Act as a liaison from EQ into other parts of the GSK business and sites and help ensure proposals/actions support compliance, interpret and communicate agreed strategy, feedback any issues or further requests for info, ensuring supporting data is provided in a suitable format, and escalating any risk or misalignment.

8. Being the key point of contact for systems and provide user support to the EM/EQ teams; Escalating risks or misalignment; high level involvement in implementing digital data tools/systems/solutions

9. In certain cases, the Quality Systems Lead may have additional responsibilities. These include, but are not limited to: Acting as process owner in digital projects, ownership and management of change controls and supplier change notifications, acting as a key interface and SME between Business and IT and Tech organizations for the development and integration of new digital solutions.

• Science degree or experience in pharmaceutical manufacturing and Quality operations
• Knowledge of quality systems principles and practical application
• Knowledge and experience applying cGMPs, with an ability to interpret those in a fast-paced environment
• Excellent command of English, other language is an asset
• Good verbal and written communication skills
• Good interpersonal, influencing and negotiation skills; with demonstrated ability to link to stakeholders around the business to ensure appropriate implementation and to persuade internal and external stakeholders to buy-into a specific course of action
• Demonstrated ability to work and collaborate in a matrix organization, across multiple and geographic boundaries and work independently with minimal supervision
• Technical knowledge of manufacturing, quality change and regulatory activities related to pharmaceutical products

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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).

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