Business System Analyst

GSK•Durham, PA

16h

About The Position

The Business System Analyst is responsible for features within, and integrations to, Product Development Lifecycle Management (PDLM) that manage product and process knowledge. The role supports digital product profiles, recipe libraries, and related capabilities, helping development, clinical and commercial manufacturing, QC, and specifications teams turn business needs into a clear product vision and actionable backlog. It focuses on making digital recipes and associated data easier to define, maintain, and reuse. The analyst works with business users and enterprise technology teams to shape and deliver PDLM features, including emerging AI-enabled capabilities. The role supports recipe and method library management in line with agreed principles such as ISA-88, and helps ensure digital products are usable and trusted as a single source of truth across sites and programmers. Digital product profiles and recipe libraries also provide product and process data for downstream systems supporting batch execution and digital submissions, such as DCS, MES, LES, ERP, and regulatory information management systems. The position collaborates with Solution and Enterprise Architects on design options and integrations but does not own architecture. It also supports product measurement, adoption, change management, and responsible use of AI-assisted tools, validating outputs for accuracy, security, GxP/data integrity, and maintainability.

Requirements

Bachelor’s or Master’s degree in Computer Science, Information Technology, Engineering, Business, Life Sciences, or a related discipline, or equivalent relevant experience.
At least 7 years of experience in product management, business analysis, digital solutions, technology delivery, or process-led technology roles.
Experience working with QC, analytical, or regulatory teams on method, specification, or quality-data problems.
Experience defining and prioritizing epics, features, user stories, and acceptance criteria, and managing a product backlog.
Experience working directly with business stakeholders to translate needs into feasible, value-led technology changes.
Experience guiding Product Analysts, Engineers, Architects, and Testers through refinement, design, testing, release, and adoption.
Experience applying security, data protection, quality, validation, change, and service-readiness controls.
Experience prioritizing based on value, process impact, risk, cost, capacity, and technology dependencies.
Experience defining product performance measures and using user, process, stability, and service insights to improve outcomes.
Experience working in agile or iterative delivery environments and coordinating suppliers or external delivery partners.
Exposure to systems that consume product and process data, such as MES, LES/LIMS, ERP, or regulatory tools.
Practical use of AI-assisted tools for analysis, documentation, or backlog refinement within Responsible AI, data privacy, cybersecurity, and GxP controls.

Nice To Haves

Certifications in product ownership, agile delivery, business analysis, change, process improvement, or service management.
Clear written and verbal communication, including the ability to explain product decisions and technology constraints to non-technical stakeholders.
Strong facilitation skills for discovery, backlog refinement, prioritization, demonstrations, and acceptance discussions.
Analytical judgment to balance value, risk, cost, complexity, urgency, and operational impact.
Ability to interpret process information, user feedback, and product data to identify improvements.
Working understanding of architecture, integration, data, security, validation, service, and operational readiness.
Strong organization, traceability, and documentation discipline.
Collaborative approach and ability to work across global, cross-functional, and supplier teams.
Commitment to user-centered, capability-led, and technology-agnostic solutions.

Responsibilities

Partner with development, clinical, commercial, QC, specifications, and tech transfer stakeholders to understand how product and process information is created, changed, and used, and translate needs into product outcomes for digital product profiles, recipe libraries, and PDLM features.
Define and maintain the product vision and roadmap for digital product profile and recipe-library capabilities in PDLM, aligned with domain strategy and broader CMC and manufacturing digital plans.
Collaborate with business and technology stakeholders to prioritize PDLM and related-tool epics and features, including AI-enabled capabilities, considering business value, risk, effort, and dependencies.
Support management of process-action, material, and equipment-class libraries; help business lines define and maintain these building blocks and encourage consistent recipe and method structures.
Promote adherence to agreed recipe and method principles, such as ISA-88-style building blocks and clear naming, and ensure digital products support business approval workflows for new or changed library items.
Work with Solution and Enterprise Architects to agree design options for PDLM features and integrations that are secure, scalable, supportable, and compatible with existing lab, manufacturing, and data systems; architecture ownership is not part of the role.
Help define product measures, such as digital-recipe adoption, library-item reuse, time to update methods or specifications, and user feedback, and use insights to improve priorities and usability.
Coordinate with LES/LIMS, ERP, MES, DCS, and regulatory systems teams so digital product profiles and recipe libraries can be consumed for batch execution and digital submissions.
Help define PDLM’s role as a trusted source and how data is exposed or transformed to avoid recreating information in multiple places.
Support adoption and change with business champions and Product Owners through communication, training, onboarding, and practical support materials.
Use AI-assisted tools appropriately for feedback analysis, backlog development, and product documentation, validating outputs for accuracy, security, GxP/data integrity, and maintainability.