Temps Plein Written Standards & Training Manager
Description de L'emploi
Ville: Wavre WBR BE
– Relevant Bachelor and/or Master of Science Degree Process design and simplification, Learning and Education from recognized University.
– At least 6 years of professional experience including at least 4 years of relevant experience preferably within Pharmaceutical R&D
– At least 4 years of proven experience of individual responsibility for developing, managing and delivering outcomes to deadline within a project.
– Relevant experience in quality management, compliance, quality assurance, regulations/WST management.
– Previous matrix team experience and organizational awareness.
– Experience in a training and/or written standards environment is preferred
The purpose of the job is to partner with specific Platform/RDCs to ensure the appropriate lifecycle management of their written standards and training (WST). Under the guidance of the Performance, Process & Risk Manager lead for the Platform/RDC, the individual will act as a primary point of contact with respect to Written Standards & Training to establish annual plans and provide support for Written Standard change requests as well as Training requests. The individual should have subject matter expertise in the Platform/RDC area such that they can provide useful advice on Written Standard change requests (e.g. identifying dependencies , opportunities for simplification, as well as risks with implementation plans) and be able to summarize changes to those who are not subject matter experts. The individual will also consult with the Platform/RDC representatives to advice on the optimal training strategy for training requests. The individual may help organize and operate as the secretary of the Platform/RDC Written Standard and Training Committee and help ensure the appropriate alignment with the transversal Written Standards and Training Board.
Provide pro-active support and advisory to RCDs & Platforms for written standards and training
• Act as primary point of contact for an RDC & Platforms’ Written Standards & Training questions, requests and issues
• Evaluate and build recommendations for RDC & Platform leadership on WST impact of process changes (e.g. change initiatives), Risk mitigation, CAPA, or transversal changes ((e.g. across RDC/Platforms, Corporate, Vaccines, Pharma, GIO or Sites)
• Build recommendation for RDC & Platforms leadership to prioritize WST plan (WS development, change request, trainings, etc.) and update/creation of training matrices
• Partner with WST Operations Manager to provide required WST front line support to RDC & Platforms for audits and inspections
• Share best practices across/within RDC & Platforms
Manage lifecycle of written standards (WS) and training
• Ensure WST standards & governance are enforced within RDC & Platforms (cfr. new SOP development, change request process, templates, reports, systems, WST board)
• Maintain an up to date list of WS and Training assignments per assigned Platform/RDC.
• Maintain annual plan for expected changes and assignments per Platform/RDC
• Maintain engagement with Platform/RDCs process owners to ensure understanding of WST standards
• Maintain list of CAPAs impacting WST per assigned Platform/RDCs
Manage Change Requests for assigned RDC (R&D Center) or R&D Platforms
• Support the business for the filling of Change request form, advising on content to be entered, verifying if the request is in line with agreed Standards for Written Standards and Training. Ensure that the Change Request is submitted to the appropriate WST Committee in a timely manner, and that the appropriate due diligence has been completed. Ensure the proposed training strategy is appropriate per the request
Support Written Standard development for assigned RDC (R&D Center) or R&D Platforms
• Ensure that WS are readable, describing complete processes and done according to GSOP 90000044414 “Management of Written Standards”.
• Engage with stakeholders to ensure :
o Minimum necessary number of WSs for stakeholder owned processes,
o Regulatory requirements are included in the WSs
Manage training matrices for assigned RDC (R&D Center) or R&D Platforms
• Support function heads in the development of training matrices for their staff based on job descriptions and competencies.
• Partner with Platform/RDC to ensure the training matrices are kept up to date
• Coordinate yearly review of accuracy of content of training matrices & assignment to staff
Manage training development
• Act as liaison link between process owners and training designer (cfr. GLD) for new training development or training update
• Ensure training material is developed in line with requirements
Set up quarterly sessions for assigned Platforms / RDCs as needed
• Instructor-led sessions for business critical training (F2F and remote)
• Q&A sessions for recent training implementation as 20% of 10-20-70 approach to provide a forum where staff and process experts can connect
Establish WST network, align processes and implement best practices for assigned Platforms/RDCs
• With points of contact in platforms / RDCs to ensure training needs are met
• With Written Standard and Training Coordinators to ensure operational aspects
• With learning professionals in Global Learning & Development to ensure smooth implementation of new trainings
• With business trainers to ensure high quality instructor-led trainings
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.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation’s three priority diseases – HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we’re looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
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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