Site Name: USA - Pennsylvania - King of Prussia
Posted Date: May 1 2023

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 operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery 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.

As a Biopharm Quality Assurance Manager, you will be responsible for effectively managing the quality of GMP activities for contracted manufacturing sites to meet both regulatory and GSK expectations. This includes internal and external partnering to address potential issues, harmonizing the quality standards and simplifying processes while driving both compliance and efficiency

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Ensure that the third party assessments are available to support material release
• Perform internal assessments to measure compliance with appropriate GSK policies and procedures.
• Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval.
• Develop and deliver GxP training to business partners.
• Approve GMP documentation, including Standard Operating Procedures, validation documentation, change controls, and other controlled documents from business partner areas.
• Provide project support including pre approval audit activities.
• Conduct review of completed batch and/or packaging records.
• Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
• Generate and approve relevant release documentation
• Write Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems.
• Generate, review and approve batch and/or packaging record templates.
• Perform material release activities (US Only)

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 3+ years experience working to cGMPs
• 3+ years experience with manufacturing batch record review
• Bachelor’s degree in scientific discipline
• 3+ years experience supporting quality deviations, change controls, and equipment validation

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience with biopharm manufacturing
• Possess a strong quality mindset
• Excellent communication and engagement skills
• Strong partnership and collaboration skills

Why GSK?

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 impact the health of 2.5 billion people around the world in the next 10 years. 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.
#LI-GSK

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 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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