CMC Report Transformation Senior Director

GlaxoSmithKline; Ware; Hybrid; GBP 150,000 - 230,000; Full time

Job summary

GlaxoSmithKline in Ware is seeking a CMC Report Transformation Senior Director to provide strategic oversight and long-range planning for the report transformation portfolio within CMC, aligning capabilities with enterprise priorities.

You will own the product roadmap, lead multi-disciplinary teams, govern AI/ML initiatives, and ensure regulatory compliance while delivering measurable scientific and business value across global DDS activities.

Qualifications

• Experience leading product management for data/software/AI/ML products in regulated environments.
• Proven ability to define roadmaps, prioritise, and manage budgets at senior levels.
• Experience transforming regulatory or technical report writing through automation or AI.

Responsibilities

• Provide strategic oversight and long-range planning for the report transformation portfolio within CMC.
• Define and own the product roadmap for report transformation within CMC.
• Lead enterprise prioritisation and resource allocation for high-value opportunities.
• Ensure end-to-end accountability for architecture, performance, validation, and compliance.
• Manage budget, people, and external partnerships.
• Lead multi-level stakeholder engagement across DDS, Regulatory, Digital & Tech and Quality.
• Measure and communicate the value of report transformation initiatives.

Skills

Product management

AI/ML product delivery

Stakeholder management

Leadership

Education

Bachelor's degree in computer science / data science / engineering / life sciences

Master's degree or PhD in a scientific/data/engineering discipline

Tools

AI platforms

Regulatory reporting tools

Job description

Job Title: CMC Report Transformation Senior Director Job Purpose 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.

Key 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.

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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 AIt 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.

Work Arrangements

• Primary Location: Ware
• Additional locations may be considered: Belgium-Rixensart Netherlands - Amsterdam UK - Hertfordshire - Stevenage USA - Pennsylvania - Upper Providence
• This role offers a hybrid working model, with a mix of on-site and remote work.
• Remote or fully home-working arrangements are not available for this role.

Closing Date for Applications

22 October 2026

Salary Range

• Belgium Salary Range / Fourchette salariale – Belgique: EUR 148,500 to EUR 247,500
• Dutch Salary Range: EUR 126,750 to EUR 211,250

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While get ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.