Overview

role focused on ensuring best practices and compliance with global technical standards. Acting as a site expert, they support consistent adoption and implementation of technical standards defined by global MSAT teams. The SME will work within a matrix environment, collaborating across sites and participating in Communities of Practice (CoPs) and task forces alongside global MSAT Standard SMEs. By facilitating knowledge sharing, driving performance improvements, and enabling alignment with regulatory and industry expectations, the SME plays a key role in advancing sterile manufacturing capabilities at the site level. Site Standard Lead will have an indirect reporting line into global MSAT Business Process, Standards and External Manufacturing organisation. In this role you will… Technical Leadership

• Serve as the main technical expert for SUS and E&L, responsible for material selection, system design, and sterility assurance. Conduct risk assessments to address E&L hazards across processes and materials, while evaluating new technologies to enhance manufacturing safety and efficiency.

Standards Development and Implementation

• Accountable for the definition and roll-out of GSC technical standards and associated tools/templates. Responsible for the adoption of standards through coaching and mentorship. Establish governance frameworks to oversee the successful delivery of compliance and improvement projects at site levels.

Site Capability Development

• Foster capability-building by mentoring site MSAT teams in SUS/E&L best practices and practical problem-solving. Provide technical training on emerging regulatory requirements and continuously evaluate team readiness for implementing new technologies.

Continuous Improvement and Collaboration

• Actively participate in Communities of Practice (CoPs) and global initiatives to drive standardization and innovation. Lead improvement programs that enhance manufacturing efficiency and compliance. Define and track KPIs to measure the effectiveness of technical standard implementation.

Regulatory Awareness and Compliance

• Stay updated on regulatory guidance, industry standards, and global inspection trends related to SUS and E&L. Enable the implementation of best practices and compliance measures to meet international manufacturing requirements (e.g., FDA, EU GMP Annex 1).

Collaboration and Global Project Delivery

• Work closely with global MSAT leaders and site SMEs to align site operations with global standards. Support the delivery of GSC initiatives focused on continuous improvement and innovation, ensuring consistent implementation across sites.

Risk Management and Operational Support

• Lead comprehensive risk assessments to evaluate E&L hazards, including extractables testing and leachables profiling for product contact material and equipment. Oversee contamination control strategies and verify the operational integrity of components such as filters, media bags, and tubing.
• Bachelor's/Master's in Chemical Engineering, Pharmaceutical Sciences, or relevant fields.
• Extensive experience required in relevant technical standard with proven application and delivery in one or more of the following areas:
• + E&L + SUS

• Previous experience of working with multidisciplinary teams
• Risk Management/ Project Management experience (qualification preferred e.g. Prince 2, PMP)
• Regulatory knowledge related to the specific expertise
• Strong technical writing and communication skills, Autonomous, proactive, with a positive and constructive attitude
• Ability to negotiate and influence a wide range of staff at different levels of the site and in different discipline areas
• Evidence of leading improvement activities in a matrix environment
• Ability to plan, organize and control workloads to meet deadlines and deliver schedule targets
• Ability to multi-task and work accurately under pressure

GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases, and as a key supplier of some of GSK's blockbuster products, the site contributes revenues of ~$2Bn annually., Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK The Site SME for Single-Use Systems (SUS) and Extractables & Leachables (E&L) is a critical