Senior Advisor - Site Services (Quality Assurance)
The Quality Assurance function helps to protect GSKs on-going business and reputation through ensuring compliance with current requirements and alignment of manufacturing standards with evolving regulatory and legislative expectations. Failure in the above could lead to patient and compliance risk, interruption of supply, and regulatory action leading to negative impact on GSK's reputation.
As Senior Advisor to the Site Services (Quality Assurance) function, you will be part of the Quality Assurance team responsible for quality oversight of GMP activities associated with facilities and equipment performed at all US and UK Pharma R&D sites. You will be empowered to drive global harmonization and efficiencies, define and implement process improvements, and provide expert advice to site operations and support areas on regulatory requirements. Specifically, you will be responsible for providing oversight for a wide-range of external companies who provide outsourced services to GSKs R&D sites. These services effectively keep GSK's R&D sites focused on providing GSK with the next generation of medicines. The outsourcing companies provide services ranging from laboratory support and GMP cleaning, to engineering and laboratory instrument services. As Senior Advisor you will oversee all elements of the quality assurance process in relation to these companies and what they deliver for GSK's R&D sites. This will include the provision of Quality Assurance support for Quality Investigations, supporting Regulatory Inspections and managing any high-risk non-compliance issues. You may also be involved with leading (or supporting) external third-party assessments of GMP services and material providers.
This role would suit a driven and motivated individual who has strong experience of working in a complex quality management environment. You will have excellent people skills, and a proven ability to drive performance is a must. It is imperative in this role that you demonstrate an ability to drive common-objective thinking, with a complete focus on providing solutions. You will need to be persuasive, have a strong continuous improvement mindset, and have proven experience dealing with diverse stakeholder groups.
Applicants must demonstrate in their application how they meet the above criteria in order to be successful for interview selection.
CLOSING DATE for applications: Wednesday 17th October (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.
• Relevant qualifications and / or experience.
• Broad knowledge of the R&D / GMS Pharma business and network across all key business functions.
• Experience working in a regulated, GMP/GDP environment.
• Strong technical writing ability.
• Strong attention to detail.
• Detailed knowledge of the existing and emerging regulatory environment.
• Fluent in written and spoken English
• Excellent knowledge in the areas of Quality Management Systems, Regulatory and legal requirements governing the manufacturing and supply of medicinal products.
• Experience facilitating large workshops and managing complex stakeholder groups.
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
You may apply for this position online by selecting the Apply now button.
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