Site Name: China - Beijing - Chao Yang District - Ocean International Centre - Tower A
Posted Date: Oct 22 2024
Job Purpose:
Lead introduction of new and established products into China, ensuring in depth knowledge of country requirements to support right first time launches. (Including lead analytical method transfers to the 3rd Party Labs and commercial product testing according to local regulatory and GSK requirements in order to support new product introductions and the release of commercial batches.)

Key Responsibilities:

• Accountable for providing the quality standards for product launch within the China market.
• Manage and provide the vision, strategy and leadership oversight on all analytical responsibilities of GSK products within China.
• Accountable for quality activities for GSK product launch and commercial testing in China including sample/reagent management, analytical tech transfer and documentation support.
• Oversee the analytical technology transfer of methods and testing strategies from GSK/ CMO donor sites to the 3rd Party contract testing labs in China.
• Oversee the analytical testing of commercial products in China, incl. out of specification results handling and investigations.
• Maintain open communications and quick escalation with internal and regional stakeholders (in Quality, Commercial, Regulatory).
• Develop quality work processes to support the relevant analytical activities. These may include authoring or reviewing templates, guidelines, SOPs, policies or project plans.
• Review or author protocols, reports and other documentation related to technology transfer plans in China.
• Work closely within and across functional matrix teams to ensure successful registration and local market release testing.
• Manage contracts, compliance standards and performance review associated with 3rd Party contract testing laboratories.
• Ensure all analytical activities are compliant with the local regulations and GSK Quality Management System.

Knowledge/ Education / Experience Required:
A. Educational Background:
1. Minimum Level of Education: BA/BS degree or equivalent in experience, Scientific or engineering degree.
2. Preferred Level of Education: Master's or Ph D, Scientific or engineering specialization.
B. Job-Related Experience:

• Minimum Level of Job-Related Experience required : >5 years’ experience in Quality function in a highly regulated environment (China specific requirements). 5 years in a quality management position in manufacturing or analytical testing and release.

C. Other Job-Related Skills/Background

• Strong interpersonal skills with demonstrated ability to engage, empower and influence people.
• Strong leadership skills to motivate, engage and develop team capabilities
• Ability to drive change and continuous improvement
• In depth understanding of c GMP and regulations applicable to GSK in the relevant countries. (FDA/EU/WHO and other countries)
• Ability to evaluate product/technical compliance and quality issues and make sound recommendations regarding problem resolution.
• Ability to work transversally in matrix organization, with global perspectives
• Ability to make independent decisions even under pressure and navigate in grey zones
• Ability to communicate complex information both orally and in writing.
• Ability to adapt, work under uncertainty and accommodate flexible work demands.

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.

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