External Manufacturing 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 Manufacturing 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.
External Supply Quality Lead
Key Responsibilities:
Building and managing the relationship with CMOs for the designated products.
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 Quality Systems by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions.
Why you?
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 working on the shop floor in different production plants and for different companies.
Demonstrated ability to work and collaborate in cross-functional teams.
Fluent in written and oral English.
Experience in applying CGMPs and ICH guidelines.
Advanced knowledge of quality systems principles and practical application (especially management of deviations, OOS and change controls).
Experience working in a similar role.
Why GSK?
What we offer:
Career with purpose - whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.
Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services).
Hybrid working model ( 2/3 days per week in the office).
Career at one of the leading global healthcare companies.
Supportive & friendly working environment.
Corporate culture, based on being Ambitious for patients, Accountable for Impact and Doing the right thing, which powers our purpose, drives delivery of our strategy and helps make GSK a place where people can thrive.
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
#LI-GSK #LI-Hybrid
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.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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