Quality Management Systems Manager
il y a 1 semaine
Site Name:
Belgium-Wavre, Durham Blackwell Street, UK - London - Brentford, UK - North Ayrshire - Irvine
Posted Date:
Jun 7 2023
Quality Management Systems Executive (One-year contract):
As
Quality Management Systems Executive you will provide support and project leadership to maintain and improve a simple, agile cGMP/GDP Quality Management System that makes compliance straightforward, is easy to understand and implement - via the three QMS work pillars:
- Lead improvements to the GSK Quality Management System, through of the end to end simplification and operational performance projects
- Enable and support users in the local implementation of the QMS
In this role, you will be...
- Providing technical/strategic QMS input to and support at relevant QMS and Quality Governance forums. This may include acting as delegate for a QMS Executive Director.
- Upholding and deploying internal QMS Operating Principles, processes and standards to ensure the QMS remains current, compliant and aligned to the QMS Vision. This may include contributing to or leading process optimisation projects
- Where responsible for defined QMS content ensuring it is published on time, maintained and easily accessible to users
- Acting as effective change agents for defined QMS improvement projects.
- Liaising with relevant SMEs across key Rx/Vx business areas (R&D, Operations, LOCs, Global Functions) to provide input to the development and review of new QMS content. Includes global process owners (where relevant). Facilitating SME teams to generate new or revised QMS content.
- Supporting the network of QMS Champions and local SMEs across the organisation providing twoway communication on changes to QMS content. Supporting QMS Executive Director on the establishment of key stakeholder relationships across the organisation (beyond SMEs and QMS Champions).
- Via stakeholder networks and targeted GEMBA activities, identifying stakeholder needs, QMS improvement opportunities and QMS implementation good practices. Supporting RCAs and action plans to deliver QMS improvements.
- Inputting to the delivery of the QMS communications strategy across the stakeholder network
- Responsible for the creation, maintenance and optimisation of defined QMS content in alignment with key regulations, changing legislation, business changes, internal and external intelligence, identified user/stakeholder needs and business performance opportunities. Ensuring all QMS content is aligned to the QMS operating principles and standards. Includes responsibility for leading periodic reviews and managing outofcycle change requests.
- Supporting the delivery of robust processes to support and enable easy QMS implementation including gap analysis, impact assessment and training materials. Supporting activities to increase the capability of QMS Champions and Local SMEs in effective implementation of the QMS
- Promoting and monitoring deployment of the QMS aligned with a Quality mindset/culture
_ Please note that depending on your profile and experience we may offer to employ you in the grade different from the position grade._
Why you?
- Basic Qualifications: _
- University Degree chemistry, Biological Sciences, Pharmaceutical Science, Bio or Chemical engineering, or related field
- Postgraduate time in the pharmaceutical /biological industry
- Excellent knowledge in the areas of Quality Management Systems as well as current/emerging regulatory and legal requirements governing the manufacturing, supply and distribution of products
- Good technical writing ability and plain language skills.
- Proven ability to review and assess technical information ensuring delivery of user focused, fit forpurpose, simple content
- Has broad knowledge of the GSK business together with an established stakeholder network across key business functions and QMS users.
- Customer focused and able to identify/address user needs
- Preferred Qualifications:_
- Flexible thinking
- Coaching
- Good knowledge of quality and risk management principles and tools.
- Facilitation skills and experience of managing projects
- Global perspective; cultural sensitivity
- Ability to withstand pressure and to prioritise effectively.
- Selfmotivated; eye for detail and able to follow processes
- Change management and agency
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 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 positively impact the health of 2.
5 billion people by the end of-
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