Head, Gsk Quality Management System
il y a 1 semaine
Site Name:
UK - London - Brentford, Belgium-Wavre, Durham Blackwell Street, Upper Merion
Posted Date:
Jan
Head, GSK Quality Management System:
Job purpose:
This role acts as the Head of the GSK Quality Management System [QMS], which is effective over the whole of Global Supply Chain (GSC) and multiple global functions and is responsible for providing a QMS that is aligned with current regulatory expectations.
Key Responsibilities will be:
- Ensure compliance of the QMS to regulatory requirements fit for the future and will make compliance straightforward
- Drive a One Quality approach supporting the integration of Medicines and Vaccines delivering simplified and standardized approach to the QMS across the business. Embed design principles to enable agility of the QMS to account for new ways of working
- Be accountable for design and oversight of a defined programme and tiered governance structure that supports a Business as Usual (BAU) operation and can incorporate oversight of significant change programmes
- Support integration of R&D to the QMS in a phase appropriate approach
- Maintain an industry leading QMS enhanced via benchmarking through industry groups and external forums (e.g. QMS Heads Forum)
- Develop the QMS to align with GSK strategy and vision
- Look for opportunities to drive digital innovation to increase accessibility and relevance of the QMS content
- Be a member of the GSK Quality Council supporting identification areas for the QMS
- To take accountability for operational management of the One QMS team
- Lead a QMS team operating structure that can:
- Develop, manage and perform the QMS topic hub reviews [including periodic reviews] effectively and to a consistently high standard aligned to the defined schedule
- Work in partnership with the content owners (owners of the technical content), ensuring that the materials developed/updated have the line of sight to the inscope regulations
- Develop and deploy strategies to exploit technology and media in order to enrich the user experience, provide effective communication, training and improve quality culture and behaviours across the organisation to deliver QMS compliance and continual improvement
- Support Global Business Process Owners (GBPO's) in identifying learning needs and deployment gaps and contribute/facilitate the execution of agreed enterprisewide improvement projects to improve the deployment and use of the GSK QMS and ultimately drive product quality
Requirements:
- Minimum: Degree in Life Sciences, Regulatory, Engineering or Quality Subject
Preferred:
Post graduate degree for example Masters or doctorate
- Experience in Drug or Vaccine Development, Manufacturing or Quality Function
- Proven ability to lead in a matrix role through empowerment
- Demonstrated effective interpersonal, communications and negotiation skills for a wide variety of audiences, including senior management
- Problem solver, innovative, creative with operational delivery solutions
- Business acumen in balancing value creationriskcosttime
- Ability to coach and mentor staff across the organisation
- Passion, excitement, and enthusiasm for the QMS
- Detailed knowledge of Regulated Quality, Manufacturing & GMP/GDP requirements
- Ability to utilize experience and influencing skills to achieve system transformation, implementation, stakeholder management and issue resolution
- Demonstrated successful project leadership and change management skills applied in a Manufacturing Operations Environment
- Awareness of Emerging Regulatory and Quality Trends
LI-GSK
Why Us?
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 organization 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 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.
We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK wor-
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