CMC Report Transformation Senior Director

GSK•Upper Providence, PA

8d•€148,500 - €247,500•Hybrid

About The Position

To provide strategic oversight and long-range planning for the portfolio of Report Transformation tools and strategies within CMC (Chemistry, Manufacturing and Controls), defining the vision, strategy, and roadmap that determine how capabilities are prioritised, resourced, delivered, and scaled across the function. This role takes the Drug Development and Supply (DDS) lead role for the SONATA (GSK’s automated and digital regulatory report creation) programme and acts as representation and decision maker on all senior governance forums as well as orchestrating the delivery required on a more local level. In addition, the role is accountable for the transformation of all technical report writing across DDS and for the realisation of benefits of implemented tools and reimagined reporting. The role is ultimately accountable for determining and realising the value of report transformation within the regulated CMC environment, ensuring solutions are scientifically robust, responsibly governed, and demonstrably impactful.

Requirements

Bachelor's degree in Computer Science, Data Science, Engineering, Life Sciences, Regulatory Affairs, or a closely related scientific or technical field.
Experience in product management and product leadership, delivering data, software, and AI/ML products
Experience operating at director level or above, and substantial experience setting enterprise strategy for and delivering complex, production-grade AI products ideally including agentic or autonomous AI within a scientific, healthcare, or pharmaceutical (CMC) environment, including direct experience transforming regulatory or technical report writing and documentation processes through automation, digital tooling, or AI.

Nice To Haves

Master's degree or PhD in a scientific, data science, or engineering discipline, or relevant product and AI certifications (e.g. Pragmatic Institute, Certified Scrum Product Owner, cloud/ML platform certifications)
Working knowledge of GxP computerised system validation principles (e.g. GAMP 5) as applied to automated content-generation and reporting tools.
Familiarity with CMC regulatory report types and submission formats (e.g. stability, validation, and batch reports; eCTD Module 3 structure) and the standards governing their content.
Practical knowledge of natural language generation (NLG), large language model (LLM), and structured/templated authoring technologies as applied to regulated scientific documentation.
Familiarity with relevant regulatory and industry guidance (e.g. ICH, FDA, EMA) on the use of automation and AI in generating regulated content.
Experience with electronic quality and document management systems (e.g. VQD or equivalent) used to author, review, and approve CMC documentation.
Working knowledge of data privacy, information security, and intellectual property considerations relevant to deploying AI tools in a life-sciences environment.
Experience holding technical accountability for production tech products, including architectural, data, and performance trade-offs.
Ability to lead and collaborate effectively with scientists, senior leaders, regulatory, quality and software development teams.
Experience evaluating, integrating, and governing third-party AI/data platforms and partnerships.
Understanding of the CMC development and manufacturing lifecycle sufficient to interpret technical content and ensure report transformation tools preserve scientific accuracy and regulatory compliance.
Familiarity with agile and product delivery methodologies (e.g. Scrum, SAFe) as applied to software and AI product development in a regulated setting.
Demonstrated success building, leading, and developing high-performing teams and senior talent within a large, matrixed global organisation.

Responsibilities

Provide strategic oversight and long-range planning for the report transformation product portfolio within CMC, setting direction that aligns autonomous capabilities with functional and enterprise priorities.
Define and own the product roadmap for report transformation within CMC, sequencing investment and delivery to maximise scientific and business value over the short, medium, and long term.
Lead enterprise-level prioritisation across competing demands, making transparent, evidence-based trade-offs to focus resources on the highest-value report transformation opportunities.
Hold end-to-end technical accountability for report transformation strategy and products, ensuring solutions are architecturally sound, performant, validated, and fit for use in a regulated CMC setting.
Hold full accountability for the people, budget, and delivery resources needed to execute the portfolio, including senior recruitment and organisational design decisions, spanning internal teams and external technology partners.
Lead complex, multi-level stakeholder management across the scientific, technical, quality, and senior leadership communities, building alignment and securing sponsorship for agentic AI initiatives.
Determine, measure, and articulate the value of report transformation products, defining success metrics and demonstrating quantifiable scientific, operational, and commercial impact.
Manage complex stakeholders across DDS, Regulatory, Digital & Tech and Quality organisations to ensure compliant but transformative decisions are made.
Build, lead, and develop a high-performing team of product and technical leaders, embedding coaching, talent development, and succession planning across the report transformation portfolio.
Act as the senior executive sponsor for report transformation within CMC, representing the function at VP and senior leadership forums and shaping enterprise-wide digital and AI strategy.