AdressePosted Date: Mar 7 2024
We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics.
We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.
External Supply Quality Manager (m/f/d)
Pharma External Supply (ES) is a complex global organization comprising 180 individuals across Supply, Procurement, Strategy, Technical, Quality, Artwork, Business Planning and Operational Excellence spread across c.12 regions globally. The External Supply team is accountable for GSK’s External Supply Chain, managing relationships with third party Contract Manufacturing Organizations (CMOs) to ensure GSKs operational and Quality requirements are met.
Key Responsibilities
- Building and managing the relationship with CMOs for the designated products
- Managing relationship with 2 related CMOs
- Negotiating and maintaining Quality Agreements with CMOs and receiving LOCs
- Managing risks, resolving quality and compliance issues to secure supply of quality product and ensuring these are adequately logged, tracked and maintained in ES internal systems (e.g. change controls, deviations, complaints, Periodic Product Reviews, Quality Alerts, Quality Regulatory Intelligence, quality risk model)
- Driving periodic review of CMOs Quality Systems by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions
Qualifications & Skills
- Degree in Pharmacy, a Science discipline AND/OR Masters AND/OR equivalency in education and experience
- Experience in Pharmaceutical industry, with specific experience in Operational Quality
- Experience in applying cGMPs and ICH guidelines
- Advanced knowledge of quality systems principles and practical application (especially management of deviations, OOS and change controls)
- Demonstrated ability to work and collaborate in cross-functional teams
- Drive for continuous improvement
- Fluent in written and oral English
PreferredQualifications & Skills
- Sterility assurance background
#EBDE
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 workforce.
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