CGT Compliance Leader

GlaxoSmithKline ,
Stevenage, Hertfordshire

Overview

Job Description

The vision for the Cell & Gene Therapy Platform has been to develop an end-to-end organisation, integrating discovery, development and supply functions. This ensures that ground-breaking Cell and Gene Therapy medicines are seamlessly and expertly discovered developed and manufactured for clinical development and beyond. Organisationally the Cell & Gene Therapy Platform is composed of 5 functions: Syn Bio, Discovery Research, Process Development, GMP Operations and Systems / Quality & Risk Management. GSK have an exciting role that has been created to support Compliance activities across the CGT platform and is expected to be a multi functional role covering a broad range of topics including training, metrics, documentation systems and processes, QMS, audit support and system administration Key responsibilities include; * Support QRM manager / Head Systems & QRM with implementation improvments to quality and compliance systems and processes * Support QRM manager / Head Systems & QRM to develop new and alternative methods for training that are tailored towards a relatively new platform e.g small group training for key compliance area. * Support delivery of training systems and processes * Escalating for awareness, consideration and action concerns/ risks which may impact or disrupt delivery of medicines in the pipeline * Integrating culture, policy and procedure, people and processes, products and patients so that quality, riskand compliance arepresent in efforts to deliver medicine to patients; and, do so in such a manner as to streamline work without overburdening existing resources Closing Date for Applications:9th June 2020 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? Required Qualifications and experience: * B.Sc. with relevant industry experience * Must be able to work in a team oriented, fast paced environment * Must be able to quickly respond to changing priorities * High focus on customer service * Demonstrated ability to understand and appreciate the value of diverse perspectives and drive innovative solutions to complex problems * Strong skills in Microsoft Office applications (formatting Word documents and working in Excel) * Knowledge in Good Manufacturing Practices and Quality Management System (QMS) * Understands function operating procedures and/or internal policies required to maintain quality standards and to protect GSK intellectual property * Excellent interpersonal and communication skills, adept at working with management at all levels and different geographies within the organization in both a matrix and direct reporting structure Company Details: GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We discover, make and market life-enhancing products that are used by millions of people around the world, helping them to do more, feel better and live longer. We have 3 primary areas of business in pharmaceuticals, vaccines and consumer healthcare. We have offices in more than 115 countries, major research centers in the UK, USA, Spain, Belgium and China and an extensive manufacturing network with 87 sites globally. Our three strategic priorities are to grow a diversified global business, deliver products of value, and to simplify our operating model. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/