AddressPosted Date: Jan 18 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 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 aQuality Manager - Secondary Manufacturing, you will be responsible for being the face of GSK Quality at contract manufacturing organizations (CMOs) in the Large Molecule External Manufacturing (EM LM) network focused on secondary operations e.g., drug product filling, device assembly, packaging. Ensure CMOs operate in accordance with GSK and industry practices and standards (e.g., GxPs, Annex 1) through his/her strong manufacturing/operations background. Maintain regular on-site presence during manufacturing to provide real time problem solving, support, influence, and decision making to assure the Quality and compliance of GSK’s products and maintain GSK’s reputation. Travel up to 35% unless he/she is co-located with the CMO(s) in their remit.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Provide Operational Quality (OQ) oversight throughout the product and CMO life cycle, including but not limited to:
- CMO and supply chain selection and enabling e.g., due diligence, Quality Agreements, audits, PQ readiness
- Routine operations e.g., on-site presence and Quality direction during manufacturing (e.g., real time problem solving, support, influence, decision making), deviation and incident management, batch review, batch disposition, period product reviews
- Audit/inspection e.g., inspection preparation / management / response, on-going inspection readiness
- Conduct OQ duties in accordance GSK’s standards and QMS e.g., CAPA / deviation / change control / document management, Quality Agreement maintenance, KPI reporting
- Maintain current knowledge of the GxPs and optimize GSK’s Quality Management System (QMS)
- Build and maintain strong and credible relationship across GSK and CMO functions to ensure effective OQ oversight while optimizing the quality mindset, promoting maturity, and safeguarding the quality / compliance of GSK’s products
- Maintain current knowledge of GSK and industry sterile / aseptic manufacturing standards and a strong and collaborative working relationship with the GSK Sterility Assurance SME community
- Establish, maintain, improve, and contribute to operational and governance forums: 1) Internally e.g., Quality Council, Risk Management Control Board 2) With the CMOs e.g., project meetings, Business Review Meetings, Steering Teams
- Assure potential and known issues, risks, and opportunities are communicated and managed within the GSK systems while ensuring teams, leadership, and stakeholders are appropriately engaged in a timely and effective manner e.g., escalation
- Support and deliver GSK performance and quality standards to ensure business / supply continuity without compromising quality or compliance e.g., right first time, adherence to schedule
- Lead, manage, coach, mentor, retain, and develop staff
- Proactively identify continuous improvement opportunities and deliver both improvements and benefits
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in science or engineering discipline and at least 8+ years of previous pharmaceuticals industry experience in manufacturing, technical, and/or quality role(s).
- Or Master’s degree and at least 6+ years of previous pharmaceuticals industry experience in manufacturing, technical, and/or quality role(s).
- 3+ years of sterile/aseptic drug product manufacturing experience
- Candidates from locations within the EU, UK, and US will be considered
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Matrix management experience
Operational quality experience
CMO oversite or external manufacturing
#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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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