Purpose

The purpose of this job role is to contribute to the effective management of the supply base. This involves owning the Quality Agreements/ Product Requirement Specifications processes for Supplier and CMOs, Compliance Documents process and execution of Quality Agreements/Compliance Documents for Suppliers to support quality and regulatory compliance requirements.

Key Responsibilities

In this role you will:

• Providing process ownership and KPIs oversight for Quality Agreements/ Product Requirement Specifications with Suppliers and CMOs. Initiating, negotiating, completing and maintaining Quality Agreements within scope suppliers. Escalating if necessary to stakeholders/ line manager for support with negotiations with suppliers.
• Process ownership of Compliance Documents process. Collecting, reviewing and maintaining applicable compliance documentation for in scope suppliers. Examples of documentation, but not exhaustive, include:
  • Compliance Documentation Questionnaire
  • BSE/ TSE
  • Nitrosamine Questionnaire
• Identifying risks and communicating/ escalating/ managing per procedures to ensure management and stakeholders understand the quality risks so that appropriate mitigating actions are identified and implemented.
• Responsible for providing relevant support to GSK sites undergoing regulatory/ customer inspections. Support CAPA as required.
• Participate, as applicable, in the development of internal External Quality processes to ensure compliance with the GSK QMS (Quality Management System). Authoring/ revising assigned internal External Quality procedures/ guidelines.
• Participate in/ lead projects or management monitoring/ internal business monitoring as required. Support and train new team members/ interns as required. Obtaining and compiling relevant metrics for data analytics and trending for performance management.

Why you?

Basic Qualifications

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

• A higher education degree with basic knowledge of computer systems or adequate relevant experience that would demonstrate the ability to perform the role. Sciences (biology, chemistry, pharmacist) or engineering degree or other technical related fields.
• Proficiency in and knowledge of GSK specific systems (VQMS, VQD, Power BI, etc.), preferred.
• Experience in one or more areas: Production, Quality/ Regulatory, Supplier Management, Inspection Support.
• Good verbal and written communication skills, including ability to progress requests for information in an effective manner.
• Proficient influencing and negotiating skills with internal and external stakeholders while maintaining a good relationship with them.
• Strong data analytics and IT systems skills.

Preferred Qualifications

• Ability to identify, escalate and mitigate/ manage risks.
• Experience with digital transformation, change management.
• Awareness and understanding of local and global regulatory requirements regarding subjects such as animal derived materials, residual solvents etc.
• Awareness of GSK Production System tools and techniques.
• Demonstrated ability to function effectively across multiple cultures and geographic boundaries.
• Good verbal and written communication skills. Strong command of English. Additional language skills would be an advantage.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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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