Compliance Lead

GlaxoSmithKline ,
Barnard Castle, Durham
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Overview

Job Description

Compliance Lead (Regulatory Conformance) We are recruiting a new and exciting position for a Compliance Lead to join the Zinnat Supply Chain. The main responsibility of this role will be to oversee regulatory conformance within the newly formed Zinnat Supply chain. It is an exciting opportunity for the successful candidate to create new ways of working to develop a streamlined and simplified process. Within the Quality Compliance team, we are aiming to create a flexible team who are multi-skilled enabling continued support to the business whilst balancing work and personal life. Therefore, alongside the regulatory role, there is a unique opportunity for the successful candidate to be able to develop further by becoming involved in other areas of compliance which are of interest to them aligned to their development plan. This could include TTS, PPRs, DI, QRI, QRM, internal auditing, supporting external (regulatory and 3rd party) audits or medical devices This position would provide the successful candidate with a good foundation of Regulatory Compliance knowledge and provide the opportunity to work with every function, from internal production through to Global Regulatory Affairs, R&D, third party companies, Local Operating Companies and other GSK sites. Through development within the role, the successful candidate will build their knowledge on regulatory authority guidance in relation to Chemistry Manufacturing Controls (CMC), and regulatory compliance to support the manufacture of GSK products that comply with quality, safety and efficacy requirements The main duties of the role relating to regulatory will be: * Providing quality regulatory advice * Support central Global Regulatory Affairs (GRA) and Local Operating Companies (LOCs) with the generation, review, renewal and submission of market applications including New Product submissions. * Share regulatory expertise to ensure compliance and support regulatory inspections. * Participate in innovative New Business and change projects for the site. * Coordinate the progression of changes and Regulatory Implementation Strategies. * Provide urgent medical information to our patients to support their use of Barnard Castle products. * Actively support the End to End Supply Chain of Barnard Castle products by maintaining the licence approval status of Barnard Castle products across all markets supplied. The additional compliance learning opportunities within compliance will be tailored to the individuals interests and skills. About You: The role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, this position would suit a self-motivated individual who has demonstrable experience of working in cross-functional teams. You will have a relevant life-sciences degree and relevant experiences (E.g. knowledge of regulatory processes or equivalent experiences such as knowledge of Compliance and Auditing). Ideally you will have detailed knowledge of the Quality-Management Systems within a major pharmaceutical manufacturing site. It is also imperative in this role that you demonstrate an ability to drive common-objective thinking, with a complete focus on providing solutions. During the application process we are looking to see that applicants have a clear understanding of the complexities and importance of driving compliance within a pharmaceutical manufacturing process. CLOSING DATE for applications: Monday 11th November (COB) 2019. 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. Basic Qualifications * Degree Qualified ideally in Chemistry, Microbiology, Pharmacy or a related scientific subject (or relevant experience) * Understanding and ability to apply GxP principles * Experience in manufacturing processes and/or quality role Preferred Qualifications * Knowledge of regulatory guidance and pharmacopoeia * Familiarity with Quality and Regulatory Intelligence (QRI) * Familiarity with GMP Compliance About GSK: GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com 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

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