MSAT Technical Standards Lead (Team Lead)

GSK; Eggleston; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading global biopharma company seeks a Technical Standards Lead for its Barnard Castle site. This role involves leading a team, overseeing technical standards implementation, and ensuring compliance with regulations. The ideal candidate will possess an MSc and significant experience in technical standards related to validation and contamination control, along with strong leadership and communication abilities. A PhD is preferred. Competitive salary and benefits provided with hybrid work options.

Benefits

Competitive salary

Annual bonus based on performance

Healthcare and wellbeing programmes

Pension plan membership

Qualifications

• Experience with validation lifecycle for cleaning and contamination control.
• Proven leadership and knowledge transfer capabilities.
• Ability to work with multidisciplinary teams.

Responsibilities

• Lead and manage the team of specialists in technical standards.
• Establish governance frameworks for technical standards implementation.
• Oversee risk management and compliance for the MSAT team.

Skills

Technical writing

Communication skills

Leadership

Education

MSc in a scientific discipline

PhD in a scientific discipline

Tools

Digital tools

Project Management tools

Job description

Overview

The successful candidate will be responsible for the delivery of site Technical Standard for GSK Barnard Castle. The MSAT Technical Standards Lead leads a team of specialists at Barnard Castle, ensuring consistent application of global technical standards across legacy products and new product introductions. Key focus areas include Product Lifecycle Management (PLM), Cleaning Validation and Contamination Control, Visual Inspection, Single Use Systems (SUS), and Extractables & Leachables (E&L). The role provides technical leadership, promotes knowledge transfer through coaching, and oversees risk management and compliance for the site MSAT team. It also maintains an indirect reporting line to the MSAT Business Process, Standards, and External Manufacturing organisation.

Responsibilities

• The MSAT Technical Standards Manager leads and manages the team of specialists, ensuring they have the necessary expertise and support to deliver technical excellence in Cleaning Validation, PLM, SuS and E&L, and Visual Inspection. The manager provides mentorship and fosters professional growth within the team, enabling the specialists to independently manage their respective technical standards while optimizing operational performance across the site.
• The manager ensures that the team builds and maintains site capability in core MSAT standards by transferring knowledge and expertise across the site. This involves developing training programs, coaching the specialists, and ensuring readiness for implementation of technical standards. The manager actively works to enhance the team\'s skills and ensure alignment with global best practices.
• The manager plays a critical role in stakeholder management, working closely with Barnard Castle Senior Leadership Team (SLT), quality functions, and operations teams to ensure alignment and support for technical standards implementation. Additionally, the manager collaborates with above-site global MSAT teams to ensure seamless integration of global strategies into site-level practices. This involves negotiating priorities, influencing decision-making, and fostering strong relationships across functions to achieve organizational goals.
• The manager establishes governance frameworks to oversee the implementation of technical standards, ensuring that key performance indicators (KPIs) are in place to measure and drive continuous improvement. Additionally, the manager ensures effective risk management and compliance within the team, proactively identifying and escalating issues to prevent setbacks and ensure successful implementation of standards.
• The manager ensures that site-specific practices align with global MSAT standards, including tools, templates, and guidance. By collaborating with global MSAT Standards Leads, the manager supports the delivery of key GSC projects and initiatives, ensuring consistent implementation of technical standards across the site.
• The manager maintains current knowledge of global regulations, inspection intelligence, and industry standards relevant to the technical areas managed by the specialists. This includes staying updated on innovative technologies and evaluating their applicability to enhance manufacturing capabilities. The manager ensures that the team remains compliant with regulatory requirements while driving innovation.

Qualifications

• MSc in scientific discipline such as Scientific, Technical or Engineering with knowledge & experience on one or more of the following areas - validation life cycle for cleaning, product and process, contamination control, visual inspection or single use systems.
• Significant working experience required in relevant technical standard with proven application and delivery in one or more of the following areas: Cleaning Verification/Validation lifecycle, Process Validation Lifecycle (Stage 1- Stage 3), Contamination Control (PCCE, microbial), Visual Inspection, SUS
• Previous experience of working with multidisciplinary teams
• Strong technical writing and communication skills

Preferred Qualifications & Skills

• PhD in scientific discipline
• Risk Management/ Project Management experience (qualification preferred e.g. Prince 2, PMP)
• Strategic thinking and planning.
• Ability to lead and motivate a team.
• Attention to detail and commitment to quality.
• Proficiency in digital tools and technologies.
• Innovative mindset and ability to drive change.
• Good knowledge of internal and external quality and EHS requirements

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. 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