Enable America Jobs

Reference #: 399249 Site Name: USA - Pennsylvania - King of Prussia, GSK House, Jurong, Singapore - Jurong, Wavre Posted Date: Jun 24 2024

Lead the Quality R&D quality management of Third Parties involved in all outsourced manufacturing, analytical and distribution process steps from development to commit to phase III clinical vaccines and medicines. Provide quality leadership to the incoming material suppliers and supplier network for our externally supplied to the R&D GSK manufacturing sites, chemicals and components.

Key Responsibilities

• Accountable for setting the strategy, then translating the vision to inspire and motivate team, priority planning and ability to make high impact risk based decision making.
• Responsible for operational quality activities, such as: due diligence, set-up and implementation of quality agreements, establishment of joint quality governance and compliance frameworks, partners audit and regulatory inspections support, remediation facilitation, submissions review, launch preparation, quality systems implementation.
• Accountable for detecting, escalating and mitigating risks within area of R&D Third Party Quality.
• Responsible for the management and driving quality improvement of our R&D external network for small molecule, large molecule and vaccine.
• Accountable from a quality perspective, risk management, risk models and inspection readiness for the approval of new R&D CMO's.
• Empower, support and coach the team to drive improvements in our ways of working and that of our CMO's.
• Responsible for oversight and management of significant deviations, change control and customer incidents for R&D incoming material suppliers and CMO.
• Influence R&D functional partners and Quality R&D leadership team to ensure high quality standards and systems are in place to support manufacturing process and distribution of clinical contracted activities. Build and manage a high-performance network within the organization.
• Engage internal and external stakeholders through the organizational change to embed a fit-for- purpose quality mindset across Business Owners (internal) and Third Parties (external).
• Accountable for the OneGSK Quality integration in your area, dedicating resources to create best in class processes.

Basic Responsibilities:

• Accountable to ensure compliance with all training requirements assigned to himself/herself be addressed and in place.
• Ensure budget is managed according to GSK Finance guidelines and organizational expectations.
• Ensure compliance with cGMP, policies and procedures as required and if applicable.
• Training in site systems and QMS to deliver required actions.

Knowledge/ Education / Experience Required A. Educational Background Minimum Level of Education BA/BS degree or equivalent in experience - Area of Specialisation Scientific or engineering degree. Preferred Level of Education Masters or PhD - Area of Specialisation Scientific or engineering specialisation

B. Job-Related Experience Experience required 10 years' experience in Quality function in a highly regulated environment. Proven record of accomplishment regarding Leadership, Project Management, Continuous Improvement, Decision Making, Problem Solving, and Communication. Experience in R&D standards and processes, Quality Control, QA release and GCP/GLP auditing would be desirable.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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 medici es. 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.

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