Reference Standard and Reagent Director

TN United Kingdom; Ware; On-site; USD 151,000 - 253,000; Full time

Job summary

An established industry player is seeking a Reference Standard and Reagent Director to oversee critical reagents and analytical standards for their global network. This pivotal role involves ensuring compliance with regulatory standards and managing the supply chain of reference materials. You will lead a dynamic team, collaborate with quality assurance groups, and drive strategic initiatives to enhance operational efficiency. If you are a seasoned leader with a strong background in analytical processes and regulatory compliance, this opportunity will allow you to make a significant impact in a forward-thinking environment.

Benefits

Health Care

Retirement Plans

Paid Holidays

Flexible Work Arrangements

Qualifications

• 10+ years in R&D or GSC QC/QA project activities.
• 5+ years of leadership experience in relevant fields.

Responsibilities

• Lead the supply chain strategy for reference materials.
• Manage internal teams and ensure quality compliance.

Skills

Leadership

Project Management

Analytical Skills

Regulatory Compliance

Problem-Solving

Education

Bachelor of Science in Chemistry

Tools

VQD

VQMS

IMMS

PIER

Empower

Jchem

LNB

Archive

Job description

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Reference Standard and Reagent Director, Ware

Client: GSK

Location: Ware, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 7d9256f7c43d

Job Views: 5

Posted: 24.04.2025

Expiry Date: 08.06.2025

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 meet regulatory standards and coordinate supply to GSK sites, CMO, and LOC to support the end-to-end supply chain of products to the patient. The role involves ensuring long-term availability and lifecycle management of reference materials for existing and new GSK products, maintaining outsource partners, and managing supply and information flow to ensure a secure supply of reference materials. Additionally, the role includes managing GSK customer changes, risks, and issues related to outsourced services.

This role offers the opportunity to lead activities that advance your career, including:

1. Creating and deploying the GSC strategy for the supply of reference materials and critical reagents across the supply chain.
2. Managing an internal team overseeing the reference material and reagent supply model.
3. Collaborating with GSK Quality & Compliance groups to ensure ongoing quality compliance.
4. Assessing changes to reference materials and reagents, and determining when regulatory support is needed.
5. Ensuring Quality Management Systems are in place and effective.
6. Reviewing management monitoring and self-inspection schedules.
7. Supporting RCA and CAPA development for supply issues.
8. Assessing non-GSK customer requirements.
9. Acting as the primary contact for GSK customers for queries, audits, and data provision.
10. Responding to regulatory and customer queries, and reviewing regulatory dossiers.
11. Utilizing GSK systems and documents, such as VQD, VQMS, IMMS, PIER, Empower, Jchem, LNB, Archive.
12. Supporting auditing of outsource partners and CROs.
13. Managing relationships between outsource providers and GSK sites.
14. Identifying opportunities to improve the outsource model.

Why you?

Basic Qualifications:

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

Preferred Qualifications:

• Expertise in quality attributes and analytical technologies for reference materials
• Ability to influence senior stakeholders
• Deep knowledge of product development and QbD principles
• Strong problem-solving skills and regulatory compliance knowledge
• Experience in implementing standards and processes
• Understanding of regulatory processes for new drug registrations
• Knowledge of reference material quality processes
• Proven ability to drive transformational change

#LI-GSK

The annual salary range is $151,800 to $253,000, depending on location, skills, and experience. Benefits include health care, retirement, paid holidays, and more. Please visit GSK US Benefits Summary for details.

Why GSK?

GSK is a global biopharma company focused on uniting science, technology, and talent to combat disease. We aim to be an inspiring and inclusive workplace where employees can thrive, innovate, and grow. Join us at this exciting stage of our journey to get Ahead Together.

If you need accommodations to apply, contact the GSK Service Centre at 1-877-694-7547 (US) or [phone] (outside US).

GSK is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, military service, or other protected status.

Note to employment agencies: GSK does not accept referrals from agencies without prior written approval. All agencies must contact GSK's HR department for authorization before referring candidates. Unauthorized referrals may incur fees.

For US licensed healthcare professionals, GSK may need to report expenses related to employment processes as per federal and state transparency laws. For details, visit https://openpaymentsdata.cms.gov/.