Quality System Innovation Director - Quality for R&D
- PhD in sciences or equivalent by experience (significant amount of years spend in a research environment)
- Sound knowledge of Quality Management System in an research area
- Familiar with regulations and standards applicable to RD activities (GMP, GCP, GCLP, GSP…)
- High communication skill with ability to communicate clearly complex processes
- Interest in the areas of new IT technologies
- Build and deploy a new and fit-for-purpose Quality system for R&D;
- Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
- Generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.
- Create innovative processes/tools through novel combinations of expertise within the project.
- Investigate advanced and disruptive IT technologies to support the deployment, the use and the maintenance of the R&D Quality Management System
- Build a professional network both internally within key stakeholders (R&D, Compliance, GIO/Q, ...).
- Build and deploy a new and fit for purpose Quality Management System for Vaccines R&D
- Management & Budget in the context of setting R&D quality systems
- Drive competitive intelligence initiatives in the area of quality to benchmark with other companies and identify solutions for the Quality Management System of the future
- Build and lead a matrix team(s) and provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts.
- Coordinate the deployment of the Vaccines RDQMS with GIO/Q, Corporate QMS and control documents initiatives and RDpharma
- Engage and drive people through the change in order to embed a for-for-purpose quality mindset across R&D teams worldwide
- Develop effective program milestones, schedules and budgets, including capital.
- Employ project management tools to manage project deliverables and budgets against milestones; review and apply best-demonstrated practices, team processes, and improve operational efficiency.
- Identify and resolve issues that may jeopardize project schedules or improve project time. Seek regular input and feedback from customers and take appropriate action
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
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