Reference Standard and Reagent Director

ENGINEERINGUK; Barnard Castle; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Reference Material and Reagents Director to ensure the availability of critical reagents and analytical standards across the supply chain. This pivotal role involves leading a team to create and deploy strategies that enhance the supply of reference materials, ensuring compliance with regulatory standards. You will work closely with quality and compliance groups, manage customer relationships, and drive improvements in the outsource model. Join a dynamic organization where your expertise will directly impact patient care and contribute to a thriving workplace culture focused on innovation and excellence.

Qualifications

• 10+ years in R&D or GSC QC/QA with leadership experience.
• Expertise in regulatory compliance and analytical methods.

Responsibilities

• Lead strategy for supply of reference materials and reagents.
• Manage relationships with outsource partners and ensure compliance.

Skills

Leadership

Project Management

Analytical Skills

Regulatory Compliance

Problem-Solving

Education

Bachelor of Science in Chemistry

Tools

QMS

VQD

VQMS

IMMS

Empower

Jchem

LNB

Archive

Job description

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Site Name: USA - Pennsylvania - King of Prussia, Belgium-Wavre, UK - County Durham - Barnard Castle, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence
Posted Date: Apr 8 2025
Job Description
The Reference Material and Reagents Director is accountable for ensuring critical reagents and analytical standards are available for the GSK network. They must be of the required regulatory standards and coordination and supply to GSK sites, CMO and LOC to support end to end supply chain of products to the patient. The role will ensure long term availability and lifecycle management of reference materials for existing and new GSK products. You will ensure outsource partners are maintained, ensuring a priority service to GSK is maintained and that bulk materials are effectively supplied to the outsource partner in a timely manner, along with supporting information to maintain a secure supply of reference materials. Also, ensure GSK customer changes, risks and issues are managed and dealt with associated with the service provided from the outsource partner.

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

• Accountable for creating and deploying the GSC strategy for the robust supply of reference material and critical reagents across the supply chain. The delivery of the strategy is a key business driver in the RFT delivery of products to the patient.
• Accountable for an internal team responsible for oversight of the reference material and reagent supply model.
• Work with the respective GSK Quality & Compliance groups to ensure ongoing Quality Compliance, meeting the standards expected by GSK.
• Responsible for assessing changes to reference material and reagent supply and agree when regulatory support is required.
• QMS in use and in place for the team and direct partners.
• Accountable for the review of management monitoring and self-inspection universe and schedule, ensuring it is appropriate and effective.
• Responsible for capability in DMAIC/ Deviation support - ensuring rigorous RCA and effective CAPA development and tracking when issues in supply of critical reference materials and reagents.
• Responsible for effective assessment of non-GSK customers.
• Act as primary point of contact for GSK customers: response to customer queries, audit support, provision of data.
• Response to Regulatory and customer queries, LIC and PIRC support, review and update of regulatory dossiers.
• Responsible for ensuring the team utilises GSK systems and documents as required, eg. VQD, VQMS, IMMS, PIER, Empower, Jchem, LNB, Archive
• Support to SQAC for auditing of outsource partner and their CROs.
• Overall management of the relationship between the outsource service provider and GSK sites.
• Identify and implement opportunities to strengthen and improve the outsource model.

Why you?

Basic Qualifications:

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

• Bachelor of Science degree in Chemistry
• 10+ years of leading and executing project level activities within R&D or GSC QC/QA units
• 5+ years of experience in leadership experience
• 2+ years of execution of strategy experience
• 3+ years of reference standard experience
• 5+ years of analytical experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Expert understanding and experience of the quality critical attributes of the various dose forms and the analytical technologies required for reference materials.
• Able to influence senior stakeholders to implement change across divisions (R&D, GSC)
• In-depth knowledge of the product development process
• Excellent understanding of QbD (quality by design) principles and processes and keen understanding of the practicalities.
• Superior problem-solving skills, including the diagnosis of complex technical issues and development of practical solutions
• Extensive knowledge of regulatory compliance requirements (e.g. FDA 21st Century GMPs) as they relate to analytical methods, laboratory controls and pharmaceutical quality
• Proven track record in implementation of new standards and processes
• Excellent understanding of regulatory processes for new registrations (BLAs, NDAs and MAAs).
• Working knowledge of the application of reference materials and associated quality processes.
• Proven ability to innovate and champion transformational change

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.