Vaccines R&d Foundation Quality System Owner

il y a 3 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre

**Posted Date**: Apr 11 2023

Build, deploy and maintain one or more Vx R&D Foundation Quality System(s) in close partnership with R&D business and Operational Quality Partners, by promoting a culture of continuous quality improvement to ensure best practice in the delivery of Vx Quality for R&D and R&D objectives while meeting regulatory expectations and Internal Control Framework requirements, and to allow fit-for-purpose management of quality in R&D, including proposals for implementation of adapted or new technologies in the management of quality (Quality 4.0) in alignment with Vx Quality and R&D objectives.

**Vaccines R&D Foundation Quality System Owner**

**In this role you will **

**System Ownership**
- Define a fit-for-R&D strategy and drive implementation (both process and tool), and either deploy into a local system or monitor the implementation of R&D requirements during deployment of global systems
- Own and maintain applicable transversal and local procedures (e.g. SOPs), templates and other documents and ensure compliance with external and internal standards
- Confirm system effectiveness (identification of risk areas, identification of continuous improvement,) and provide reports to Quality and Business management for decision making and communication, and, if needed, establish an action plan to address identified opportunities
- Define training strategy and content and provide training support

**System Expertise**
- Represent Vx R&D and Quality for R&D in internal and external boards/meetings and contribute to the development of new standards
- Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative / new technologies, industry standards and registered risks
- Monitor and assess new developments, industry trends, evolving regulatory expectations
- Provide expert support to R&D and Quality for R&D (e.g. during inspections preparation and response writing, during writing of risks, observations, deviations, improvement initiatives, remediation, CAPA globalization, Quality Alerts/Quality Bulletins)

**Network Management**
- Manage internal network of local experts, maintain relationship with GSK experts from other Business units, and ensure sharing of best-practice and learnings

**The post holder delivers on part of, or all the following responsibilities**:

- Engage as Quality Lead for transformational projects that impact the wider Vaccines quality and R&D organization, as appropriate
- Facilitate Quality Governance and manage Advocacy meetings, as appropriate

**_ This job opportunity is a permanent contract _**_not_**_ opened for relocation._**

**_ Why you? _**

Qualifications & Skills:

- Master’s degree in Science or Engineering or equivalent
- 5 to 10 years of experience n Pharmaceutical/Biotech Industry, including experience Quality and continuous improvement
- Fluent in French and English

Preferred Skills
- Possess strong leadership, scientific and business acumen, and ability to manage multiple priorities, timelines and ensure compliance to all GSK policies.
- Demonstrated leadership of Continuous improvement initiatives and cultural change year on year resulting in both financial and non-financial benefit and behavioral change
- Diagnostic capability to identify improvement opportunities
- Excellent coaching and teaching capabilities.
- Demonstrated ability to lead complex problem-solving efforts to achieve business objectives

**#Li-GSK**:
GSKTechTalent

**_ Why GSK?_**:
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more:
Annual Report 2021

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.

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 o

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