Site Name: Belgium-Wavre, Durham Blackwell Street, UK – London – New Oxford Street Posted Date: Jun 24 2024 Engineering Compliance Manager (Quality) Job purpose: As the Engineering Compliance Manager (Quality), you will represent Quality working in partnership with the Business Functions and Tech teams to provide quality risk management of engineering systems, facilities, utilities, and equipment; including delivery and steering engineering compliance programme(s) to ensure quality expectations for GxP applications, service providers and data are met. In this role you will… Provide oversight and quality risk management of Engineering systems, facilities, utilities and equipment, into sites across the network. Provide advice to External and Supplier Quality Operations teams as required, supporting their work with contractors and suppliers. Responsible for the quality input and oversight of Engineering standards. Collaborate with cross-functional teams and ensure the required Quality Assurance processes are embedded. Review and quality approval of engineering incidents, issues, and investigations and to determine if further corrective actions need to be embedded into site plans. Support training activities for items such as GMP or other Quality related mandated training, as well as providing mentoring and coaching to colleagues in all relevant aspects of GMP. Author and/or subject matter expert (SME) of one or more QMS topics; support development of technical alerts / bulletins. Ensuring robust communication and escalation of Quality and Compliance issues to the Quality Management. Ensuring issues/risks are identified, mitigated and/or escalated. Review and approve documents as the Quality representative such as SOPs and technical standards / reports. Support document review and understand the impacts of change control in the area. Understand use of QMS and its application. Understanding of the regulatory requirements for the area(s) being supported. Generation and/or approval of quality agreements for engineering third parties / service providers. Assessment of engineering third party risk models, standardisation of quality across suppliers. Why you? Qualifications & Skills BEng/BA/BS or Master degree in Engineering, Pharmacy, or Science related discipline Strong background in Quality systems and/or operations within the pharmaceutical industry is appreciated 5-10 years’ experience in Engineering/ Quality function in a highly regulated environment: Experience in Quality Systems Experience in change control, deviation management, CAPA, management of 3rd parties and GMP training would be desirable. Knowledge of engineering and facility/equipment standards, including regulator expectations. Proven record in managing projects. A Project Management certification would be an asset. Fluency in English, French is an asset Preferred Qualifications & Skills: Leadership skills: ability to influence, drive decision making and/or lead change. Continuous Improvement capacities: lead or participate in continuous improvement initiatives. Excellent communication skills with ability to interact with various stakeholders at a global scale. Analytical mindset and problem-solving approach If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. 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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