Þvice Engineering Manager - Analytical and Operations Team

Nombre del sítio: UK - Hertfordshire - Ware RD Fecha de publicación: Aug 8 2022 We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Find out more: Our approach to R&D    Device Engineering Manager – Analytical & Operations Team  We are looking for an enthusiastic and experienced individual to lead Device Engineering’s Analytical and Operations team to provide support to the development of new drug device combination products. Do you enjoy a challenging role with the opportunity deliver robust products that improve the patient experience and can give them access to life changing medicines from the comfort of their own home? The role of Device Engineering Manager, Analytical & Operations team, will be part of a dynamic and growing team that are key to delivering an expanding portfolio of injectable devices.    The candidate must be a creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and across organizational and geographic boundaries as well as working effectively in team and matrix environments. The candidate must be able to demonstrate the ability for sound and timely decision-making and problem-solving skills in high impact situations. The candidate must demonstrate an ability to use electronic data & information gathering, capture, archiving and communications techniques    The role is to be based at GSK’s R&D site in Ware, Hertfordshire (UK) and can offer flexible hybrid working. Occasional travel may also be required.    In this role you will Be responsible for the management of a team that executes device testing activities to generate high quality data that underpins the development of new drug-device combination projects and new device platforms  Be responsible for identifying improvements to analytical methods, ways of working, and any test capability gaps required to enable the portfolio  Be responsible for managing and leading general concerns and risk assertions through to completion  Be responsible for ensuring our lab equipment and methods comply with GSK’s safety requirements (WERAs / Risk Assessments etc  Be responsible for managing Device Engineering’s quality and compliance strategies, programmes, trainings, and systems  Act as the device engineering representative and primary touchpoint for GSK’s internal QA and Compliance groups   Be responsible for supporting and devising internal audits of GMP and non-GMP activities (e.g., IBM, lab, management monitoring)  Be able to effectively communicate your work to the wider development team and stakeholders  Act as the primary business lead investigator (BLI), managing deviations within internal systems, proposing CAPA’s from audits and performing effectiveness checks; coordinating applicable customer complaints; critically evaluating new processes with respect to quality and compliance requirements; leading GMP and non-GMP change controls that are owned by Device Engineering.  Closing Date for Applications: 22nd August 2022 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert.  When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.  If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: A graduate in the field of Science or Engineering with direct experience of supervising teams in an analytical or a quality based function  Demonstrated application of the principles of GMP and Quality Assurance  Experience of analytical process and procedures  Experience of managing deviations / CAPA and RCA and GMP investigations  Experience of supporting internal audits  Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: Master’s in Science or Engineering Excellent verbal and written communication skills Strong problem-solving and analytical skills Line management experience desirable but not essential. 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more:  Annual Report 2021 Como empresa impulsada por nuestros valores de enfoque al paciente, transparencia, respeto e integridad, sabemos que la inclusión y la diversidad son esenciales para que podamos tener éxito. Queremos que todos nuestros colegas prosperen en GSK, brindando sus experiencias únicas, asegurándonos de que se sientan bien y que sigan creciendo en sus carreras. Como candidato para un papel, queremos que usted se sienta de la misma manera. Creemos en una cultura de trabajo ágil para todos nuestros roles. Si la flexibilidad es importante para usted, lo alentamos a explorar con nuestro equipo de contratación cuáles son las oportunidades. No dude en ponerse en contacto con nosotros si desea analizar cualquier ajuste a nuestro proceso que pueda ayudarlo a demostrar sus fortalezas y capacidades. Puede llamarnos al 0808 234 4391 o enviar un correo electrónico [email protected]. A medida que lo solicite, le pediremos que comparta alguna información personal que sea voluntaria. Esto se utilizará para ayudarnos a comprender qué tan bien estamos haciendo frente a nuestras ambiciones de inclusión y diversidad. Realmente lo agradeceríamos si pudiera tomarse unos momentos para completarlo. Tenga la seguridad de que los gerentes de contratación no tienen acceso a esta información, no se utiliza en ninguna parte del proceso de selección y trataremos su información de forma confidencial y la utilizaremos de forma anónima.