Brexit Dublin Licensing Lead

Your Responsibilities:
12 month contract

Job Purpose
To co-ordinate and plan activities required for Brexit associated with new license changes to support continuity of supply.

Key Responsibilities:
• Prepare applications for new Manufacturers / Importation Authorisations, Wholesaler Dealers Authorisations and controlled Drugs / Precursor Chemical Authorisations.
• Implement quality systems required to support licence applications
• Development of the physical location of a new QP Hub, including IT, warehouse storage and TTSs / DRAs.
• Liaison with local regulatory agency as required during the implementation phase
• Coordinate and support licence updates and new licence applications for Trading Partners and LOC's
• Support regulatory inspections where required
• Coordinate activities across different Consumer Healthcare GMS sites and Local Operating Companies (LOCs), holding owners accountable to ensure timely completion of actions
• LOC point of contact for Brexit Quality issues in Consumer Healthcare
• Coordinate and support TTS and QAA updates
• Maintain strong links of communication with all Brexit work streams and key stakeholders
• Provide routine updates on progress, risks and recommendations across GMS and commercial LOCs.
• Liaise with Regulatory and Artwork work streams to ensure interdependencies are identified and managed throughout project lifecycle

Why You?

Basic qualifications:
• Degree or equivalent level in a scientific discipline
• Fully qualified QP
• Quality Assurance for pharmaceutical production
• Minimum 10 years' experience within the pharmaceutical industry

Preferred qualifications:
• Strong knowledge of Quality Systems supporting distribution and importation
• Good knowledge of GMP and GDP and associated licencing requirements
• Regulatory inspection experience and a strong EU regulatory understanding
• Excellent organisational skills, ability to consolidate plans and drive projects forward
• Self-starter, motivated and works on own initiative
• Good communication skills, experience with senior management
• Knowledge and experience of audit processes, preparation and requirements with comprehensive knowledge of regulatory requirements
• The ability to present information in a clear and concise manner in order to support decisions and at audits.
• Ability to plan and organize to meet deadlines and deliver schedule and targets in an environment of change.
• Project management experience and a systematic approach to preparing and maintaining processes to ensure the management and tracking of transformational activities will be required.
• Understanding / ability to demonstrate use of problem solving and continuous improvement techniques
• Attention to detail at all times.

Why GSK?:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

Contact information:
You may apply for this position online by selecting the Apply now button.
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