Senior Director, Structured Component Management (SCM) Strategy, Operations & Governance

Senior Director, Structured Component Management (SCM) Strategy, Operations & Governance

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D

Position Summary

You will design, maintain, and drive the adoption of SCM standards-component definitions, metadata schemas, taxonomy, lifecycle governance, and content quality frameworks-across R&D. Ensures all SCM artefacts are audit-ready, compliant with regulatory requirements, and fit for automated downstream consumption, including AI-assisted and generative authoring workflows as these scale across R&D. This role offers growth, visible impact and the chance to shape how we unite science, technology and talent to get ahead of disease together.

Key Responsibilities

• Lead the SCM Horizontal governance operations, and provide a strong contribution to the vendor engagement and change management/adoption workstreams, in support of the Business Lead, SCM Horizontal.
• Define, document, and maintain SCM component standards: component taxonomy, metadata schemas, semantic conventions, versioning rules, and lifecycle governance (authoring through review, approval, reuse, and retirement) in collaboration with functional governance across R&D.
• Develop and maintain governance artefacts: standards documentation, decision frameworks, quality checklists, and templates for use across verticals.
• Operate the component registry: intake validation, provenance tracking, reuse permissions, change control, and audit trail management.
• Conduct standards compliance monitoring: assess adoption, identify deviations, produce compliance reports, and work with vertical teams to remediate gaps.
• Ensure alignment with external regulatory and clinical content standards (CDISC, SNOMED, MedDRA, HL7 FHIR, ICH eCTD, TransCelerate SDR) and internal GxP requirements.
• Contribute to audit and inspection readiness: ensure all governance artefacts, decision records, and component lifecycle evidence meet audit standards.
• Support evaluation of new use cases and tools-including AI-assisted and generative content authoring-against SCM governance criteria; produce structured assessment documentation.
• Advise on the governance implications of AI-enabled and generative authoring for SCM standards, ensuring components remain trustworthy, traceable, and audit-ready as automated content generation scales across R&D.
• Partner with Medical Writing, Regulatory, Quality, and Data Governance SMEs to validate and evolve standards in line with evolving programme and regulatory requirements.
• Build and deliver training and guidance materials for SCM standards across author, reviewer, and technical communities.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Bachelor's degree in Information Science, Regulatory Affairs, Life Sciences, Medical Writing, or a related field. Advanced degree or relevant professional qualification preferred. Substantive experience in content governance, standards management, or regulatory operations in a regulated pharmaceutical or life sciences environment. Practical knowledge of structured content, component-based authoring, DITA, or equivalent content modelling approaches. Familiarity with GxP requirements and audit-ready documentation practices. Experience working with regulatory content standards (CDISC, ICH, MedDRA, SNOMED, or similar) is strongly preferred. Background in medical writing, regulatory submissions, or clinical operations is a strong advantage. Experience developing training materials and supporting adoption of new standards or processes. Experience leading enterprise-scale content transformation or digital authoring programmes-including structured/component content platforms, reuse strategies, and AI-enabled or generative authoring pilots-in a regulated life sciences environment is a strong advantage.

Other Job related skills

Content modelling, taxonomy design, and metadata schema development. Standards documentation and governance framework design. Regulatory compliance and GxP content requirements. Data quality assessment and compliance monitoring. Stakeholder engagement and ability to achieve consensus across technical and non-technical audiences. Training design and knowledge transfer. Organisational change management, particularly for driving adoption of new standards and ways of working across large, cross-functional author and reviewer communities. Awareness of AI/GenAI governance considerations for regulated content generation, including human-in-the-loop review and traceability.

Working Pattern

This role is a hybrid role and can be based at any of the following locations: UK, Stevenage, USA, Upper Providence, Belgium, Wavre Canada, Mississauga.

What we look for in you

You bring a pragmatic, user-centered approach. You lead with curiosity and empathy. You make complex things simple and help teams move faster with confidence. If you want to make a meaningful impact by shaping how structured components are managed across a global science organisation, we'd like to hear from you.

Skills

• Big Data
• Business Intelligence (BI)
• Data Architecture Development
• Database Design
• Database Management
• Data Governance
• Data Integration
• Data Modeling Tools
• Data Quality
• Data Strategies
• Enterprise Data Management