Shire Jobs

Reference #: 399012 Site Name: Upper Merion, Belgium-Wavre, UK - Hertfordshire - Stevenage, UK - London, USA - Pennsylvania - Philadelphia Posted Date: Jun 24 2024

If you are an employee potentially impacted and at risk of redundancy, please add the following statement at the top of your CV: "At Risk of Redundancy".

The Commercial Laboratory Director is accountable for managing relationships with external analytical service providers as well as supporting the individual projects at those providers.  The role will work in close partnership with Global Supply Chain, matrix project workstreams, budget holders, and R&D to support analytical transfer from internal to external nodes and vice-versa. In addition, this role will support laboratory incident reports and deviations linked to QC testing, for example out of specifications (OOS).

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

Manage the analytical supplier relationships and oversee execution of analytical deliverables with contract laboratories from clinical to commercial Build relationships with analytical suppliers to deploy GSK common objectives and to ensure contract laboratories delivers to GSK standards, supplier maintains compliance with GMP requirements, and risks introduced to GSK network from use of supplier are properly managed and mitigated Continuously drive and deliver improvement across service, quality, safety, and cost which may include remediation, as needed with analytical suppliers to ensure compliance and viability of products for the long term Coordinate activities in matrix working environment to ensure products tested right first time, meet GSK standards with competitive pricing Manage and support assessments necessary to develop analytical sourcing and supply chain recommendations (e.g., RFPs, make vs. buy) Coordinate and implement finance standard work processes and ensure invoices from third-party CROs are reviewed on a monthly cadence and invoices will be submitted right first time. Provide technical, compliance, and project management oversight for contract testing laboratories through technical site visits, data review, and monitoring of key performance indicators. Support digitalization and automation initiatives of metrics and data review Accountable for generation and management of specifications and specification templates.

Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree 5+ years' experience in QC analytical labs management including oversight of contract analytical testing and implementation of digitalization and automation technologies in QC labs. 5+ years' experience in leadership

Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's Degree Demonstrated knowledge of regulated environment with extensive knowledge of GMPs, and of quality and regulatory compliance requirements for the analytical testing of products from development to commercialization. Strategic quality technical expert that can engage and define analytical strategies across multiple functions. Effectively coordinates and build long-term external collaborations with third parties. Applies technical knowledge to form new ideas, anticipates and recognizes potential problems whilst providing workable solutions and can draw sound conclusions based on complex information or expertise from multiple specialty areas. Provide analytical information to support the project team decision making process. Ensures change management is followed for analytical methods and specifications. Able to interact with peers, subordinate, and senior personnel in multidisciplinary environment. Demonstrated competency in project management Excellent written/verbal communication, presentation and effective influencing skills Works well a part of matrix teams

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 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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