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

GlaxoSmithKline

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 This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: SCM Horizontal programme leadership 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. Standards definition & lifecycle governance 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. Component registry & compliance monitoring 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. Regulatory, GxP & audit readiness 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. AI-enabled and generative authoring governance 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. Stakeholder partnership, training & capability building 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. Why You? Basic Qualification 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 UK, Stevenage, USA, Upper Providence, Belgium, Wavre Canada, Mississauga What we look for in you You bring a pragmatic, user‑centred 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. Closing Date: COP 8th August 2026 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, Google Cloud Platform (GCP) for Machine Learning, Solution Architecture, Structured Query Language (SQL) In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD0 to CAD0 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Belgium Salary Range / Fourchette salariale - Belgique: EUR 0 to EUR 0 The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a #J-18808-Ljbffr GlaxoSmithKline

Vacancy posted 2 days ago
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