CMC Report Transformation Senior Director

GSK; United States; Hybrid; USD 180,000 - 240,000; Full time

Job summary

GSK seeks a transformative leader to drive the strategic oversight and long-range planning for the report transformation portfolio within CMC. You will define the vision, roadmap, and governance that align autonomous capabilities with enterprise priorities across regulated environments.

You will own end-to-end accountability for the transformation strategy, collaborate with global teams, manage budget and resources, and lead senior stakeholders to deliver AI-enabled regulatory reporting that is

Qualifications

• Bachelor's degree in a scientific/technical field.
• Experience in product management and AI/ML products.
• Director-level experience and enterprise strategy for AI in pharma.
• Master's degree or PhD in science/engineering or AI certifications.
• GxP validation knowledge for automated content generation.
• Familiarity with regulatory reporting formats (eCTD, Modules).
• Knowledge of NLP/NLG, LLMs and AI in regulated documentation.
• Data privacy and security in life sciences knowledge.
• Proven leadership of global, high-performing teams.

Responsibilities

• Provide strategic oversight and long-range planning for the report transformation tools in CMC.
• Define and own the product roadmap for report transformation within CMC.
• Lead enterprise-wide prioritisation and resource trade-offs.
• End-to-end accountability for transformation strategy and products.
• Manage budget, people, and external partners.
• Lead multi-level stakeholder management across scientific, technical, quality and leadership teams.
• Measure and articulate value of report transformation products.
• Collaborate with DDS, Regulatory, Digital & Tech and Quality for compliant decisions.
• Build and develop a high-performing team; succession planning.
• Act as senior executive sponsor for report transformation within CMC.

Skills

Communication

Cross-Functional Leadership

Drug Development

Project Development

Project Implementations

Project Leadership

Scientific Research

Education

Bachelor's degree in a scientific/technical field

Master's degree or PhD in scientific/engineering field or AI certifications

Tools

GxP knowledge

VQD or equivalent

Job description

Responsibilities

• 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., 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.

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.
• 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.

Key Skills

• Communication
• Cross-Functional Leadership
• Drug Development
• Project Development
• Project Implementations
• Project Leadership
• Scientific Research

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.

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Salary Ranges

• 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