Senior Director, Structured Component Management Strategy, Operations & Governance

GSK

Senior Director of Structured Component Management at GSK driving adoption of standards and lifecycle governance across R&D. Leading strategic operations for component-based authoring in life sciences.

Posted 7/27/2026full-timeMississauga • 🇨🇦 CanadaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in SCM standards design and governance, ensuring compliance with regulatory requirements and alignment with external content standards. Proficient in developing training materials and leading content transformation initiatives in a regulated life sciences environment.

Highest-signal resume keywords

SCM Standards ManagementRegulatory ComplianceContent GovernanceStructured Content AuthoringTraining Development

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Hard Skills

Content GovernanceStandards ManagementComponent-Based AuthoringDITAAudit-Ready DocumentationRegulatory Content StandardsGxP RequirementsContent TransformationAI-Enabled AuthoringChange Management

Soft Skills

CollaborationLeadershipCommunicationTrainingVendor Engagement

Certifications & Qualifications

Bachelor's Degree in Information ScienceAdvanced Degree in Related Field

Industry Keywords

PharmaceuticalLife SciencesClinical OperationsMedical WritingRegulatory AffairsCDISCSNOMEDMedDRAICH eCTDTransCelerate SDR

About the role

Key responsibilities & impact

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.
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.
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.
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible working hours
Paid time off
Remote work options