What are the responsibilities and job description for the US Market Supply Quality Lead position at GlaxoSmithKline?
Posted Date: Jan 30 2024
Are you energized by a highly visible role that allows you to influence stakeholders and shape highly effective business partnerships? If so, our US Market Supply Quality Lead role could be an excellent opportunity to explore!
As US Market Supply Quality Lead, you will engage at a leadership level across the business unit, driving the strategic business plan for the business unit, supporting strategy and decision making with critical business insights.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Responsible for market release of GSK products imported into the United States as well as products manufactured/packaged by external suppliers for market release.
- Responsible for Quality operations at all Distribution centers where operations are holding GSK-owned stock.
- Responsible for NDA Field Alert Reporting and BLA Biological Product Deviation Reporting for GSK produced products and externally supplied products sold in US market.
- Responsible for Quality oversight of US market activities
- Responsible for maintenance of all GSK Establishment Registrations including foreign facilities involved in supplying the US market.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BS degree in Science or Engineering or similar relevant subject
- 8 years of experience in a quality or compliance role
- Pharma/Biotech experience
- 5 years' experience interacting with FDA (reporting, audit experience etc.)
- Leadership / People Management experience
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Knowledge and experience in application of cGMPs and Code of Federal Regulations
- 3 years' experience in cGMP auditing
- Experience of product shortage management within a Regulatory reporting framework
- Experience of working in partnership with a commercial organisation
#LI-GSK
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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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