Site Name: Belgium-Wavre Posted Date: Dec 26 2024 Job Purpose The “Computerized System Validation” Manager will be responsible for managing CSV activities (outsourced workers through FSP) who delivers fit-for-purpose Computerized System Validation activities. The incumbent will lead the team, continuously assess and adapt where/when needed the ways-of-working to ensure that the team provides and stay compliant with internal Policies, procedures and external Regulations (e.g., 21 CFR part 11, EMA Annex 4) within GSK Vaccines QC & R&D Operations Belgium. The manager will also work in partnership with a broad range of stakeholder groups such as CSV manager R&D ,Quality, Tech, Data Reduction, Data Management, SPOC DI, Integration Equipment Validation, Procurement and business to proactively define standards, identify cost saving opportunities and accelerate generation of scientific results. Key Responsibilities Implement the new EUA/DRS life cycle mgt process in QC SOP (9*43224) Deliver fit-for-purpose Computerized Systems validation to our QC customers Develop and maintain validation templates Ensure CSV Readiness and act as Subject Matter Expert (SME) for Computerized Systems Validation topics during audits and Regulatory inspections Manage Functional Service Provider (FSP) platform to deliver projects and give support with respect of Quality, priorities received and allocated budget Establish metrics and Key Performance Indicators (KPIs) to identify challenges, opportunities and implement continuous improvement changes Deliver training, coaching and mentoring on CSV matter Ensure compliance to applicable Data Integrity requirements Support the introduction of new technologies/platforms and new ways of working (e.g., Agile, CSA, …) Seek for synergies with R&D colleagues Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: University degree preferably with a scientific orientation or equivalent by experience At least 5 years of experience in a pharmaceutical or regulated QC/R&D environment, with a focus on delivering fit-for-purpose solutions At least 3 years of experience in managing a team (prioritization, resource mgmt., budget control) At least 5 years of experience in performance, risk and quality management; including risk mitigation planning and tracking, milestones and actions management At least 5 years of CSV interaction experiences with GSK Vx international sites Preferred Qualifications: If you have the following characteristics, it would be a plus: Master’s degree in Computer Sciences or Engineering and MBA. Minimum 5 years’ experience leading a large team of validation specialists Broad knowledge on infrastructure systems, equipment design and validation, maintenance and project management Good interpersonal and influencing skills allowing to interact at all levels of the organization, including senior management and to influence and lead without hierarchical authority Good knowledge of data integrity & CSV international standards Demonstrated ability to handle several projects in different stages at the same time, using initiative and imagination to meet agreed objectives and timelines Good skills in English #Li-GSK If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. 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