Process Lead (QMS - Quality Management Systems)

The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at the GSK Ware Manufacturing Site. This entails monitoring all quality related systems, improvement procedures and documentation (including analytical data and information), ensuring that products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for EU markets)., Reporting directly to the Quality Processes Director, you will be focused on developing and improving the use of key quality processes (including, but not limited to: change control, documentation management, deviation investigations, CAPA creation and management and human factors), which not only meet the QMS (Quality Management System) requirements but are streamlined, easy to use and improve compliance.,

• Improving use of key quality processes that form the foundations of the QMS. Creating simplified approaches/solutions and supporting the development (and improvement) of other Quality Processes (like Change Controls, Deviations and CAPA).
• Act as Subject Matter Expert (SME) for key quality processes in line with the expectations of the QMS, key regulators (e.g. MHRA, FDA) and central functions. Owns the procedures and standards related to processes and manages key quality processes for audits to ensure processes are robust and inspection ready.
• Collecting metrics, reviewing data, reviewing in use examples of resultant documentation and Gemba related activities to understand performance of process and to identify improvements. Provide formal updates periodically (eg; Quality Council presentations and author process performance reports).
• Manage continuous improvement framework activities to deliver change across the site (focusing on how processes are used and embedded into a continuous improvement culture).
• Develop and implement digital solutions to manage process and track performance, as well as communicate improvements across site and work with key stakeholders to secure resources to support improvement deployment.
• Represent the site at central quality sessions (eg CoPs) to ensure key messages and expectations are taken and relayed across all site functions.
• Develop and deliver training in processes through training sessions and ongoing coaching.
• Support quality process related investigations, deviations and CAPAs so they are completed consistently and aligned to the QMS principles.
• Undertake key activities to support processes such as leading site meetings and clinics., We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated individual who has strong experience of working in quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people and communication skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise a broad, varied workload are considered essential skills.,
• Relevant degree (eg; Scientific, Technical or Engineering discipline)
• Relevant experience ideally gained working in a highly regulated industry (eg; Pharmaceutical Manufacturing Facility).
• Knowledge of current Good Manufacturing Practice (cGMP) requirements within major pharmaceutical markets.
• Knowledge and application of Quality Management Systems (QMS).
  
  Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form, and the site has circa 1,500 highly-motivated and capable people working at it. The Ware site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in oral and solid dose forms, as well as operating a high-volume commercial production for respiratory devices., 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 offers a range of benefits to its employees, which include, but are not limited to:
• Competitive base Salary
• Annual bonus based on company performance
• Opportunities to partake in on the job training courses
• Opportunities to attend and partake in industry conferences
• Opportunities for support for professional development and chartership (GSK are accredited by IET, IMechE, IChemE and other professional bodies)
• Access to healthcare and wellbeing programmes
• Employee recognition programmes
If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.