AI Governance Specialist

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope

Summarize the primary purpose of the position in 1-3 sentences. Intent is to capture the work this position does and is accountable for and why the role exists as a unique position. Not intended to be a summary of all duties.

• The AI Governance Specialist is a member of the AI Governance team within the DigitalX organization's Enterprise AI Enablement team, supporting all Astellas regions. Reporting to the AI Governance Lead, the role executes and operates the global AI Governance framework day to day, running intake and risk assessments, maintaining governance documentation and controls, and supporting delivery teams so that AI and Generative AI solutions are developed and used safely, ethically and in compliance with global regulations. The role works in close partnership with the Data Governance team to align AI governance practices with enterprise data policies, standards and controls.

Responsibilities and Accountabilities

• Run the global AI Governance intake process for AI and GenAI use cases, including triage, risk tiering and coordination of reviews and approvals.
• Conduct and document AI risk and impact assessments, working with product owners and delivery teams to identify risks and agree mitigations.
• Maintain the enterprise AI inventory, risk registers, model cards and other audit-ready governance records.
• Apply AI Governance policies, standards and controls to solutions in delivery, and track remediation actions through to closure.
• Partner with the Data Governance team to align AI governance assessments and controls with enterprise data policies and standards, addressing data quality, ownership and stewardship requirements for AI use cases.
• Partner with the AI Security team and extended Responsible AI (RAI) specialists in Legal, Data Privacy, Copyright and Intellectual Property (IP) to align governance policies, use-case reviews, risk assessments, controls and approvals with security and specialist requirements, and coordinate lifecycle monitoring, incident response, remediation and escalation.
• Support testing and evaluation activities for fairness, bias, explainability, robustness, privacy, hallucination and content safety, including red teaming of GenAI and agentic solutions.
• Track changes in AI regulations and standards (EU AI Act, NIST AI RMF, ISO/IEC 42001, Japan's AI guidelines, India's DPDP Act and GxP expectations) and help update guidance, templates and checklists.
• Prepare materials for and support global AI governance forums with Legal, Compliance, Privacy, Information Security, Quality and Data Governance.
• Develop and deliver AI Governance training content, expert sessions and workshops, and support communities of practice.
• Use and help improve AI Governance tooling and workflows (for example, intake agents and dashboards) in partnership with the teams that build them.
• Produce AI Governance metrics and progress reports for the AI Governance Lead and Enterprise AI leadership.
• Identify and escalate AI risks, incidents and issues promptly.
• Follow and promote the DigitalX operating model and associated processes and policies.

Required Qualifications

• Bachelor's degree in Computer Science, Data Science, Engineering, Law, Public Policy or a related field, or equivalent experience.
• Minimum of 5 to 7 years of experience in technology, data science, risk or compliance, including at least 2 years in AI governance, AI ethics, AI risk management or a closely related area.
• Working understanding of the machine learning and GenAI lifecycle, including LLMs, RAG and agentic AI, and common failure modes.
• Familiarity with AI regulations and frameworks such as the EU AI Act, NIST AI RMF and ISO/IEC 42001, and data privacy laws including GDPR and India's DPDP Act.
• Experience running structured assessment, review or compliance processes and maintaining accurate documentation.
• Strong written and verbal communication skills, with the ability to explain technical and ethical topics to non-technical audiences.
• Strong use of Microsoft Office applications and agile project management toolsets.

Preferred Qualifications

• Master's degree in a relevant discipline.
• Experience in pharmaceutical, life sciences or other highly regulated industries, including GxP and computerized system validation.
• Certifications such as IAPP AIGP, CIPP/CIPM, or ISO/IEC 42001 Foundation or Lead Implementer.
• Hands-on experience with AI Governance tooling (for example, Azure AI Content Safety, Microsoft Purview, fairness and explainability toolkits, LLM evaluation and red teaming tools).
• Experience with Microsoft Copilot, Copilot Studio and Azure OpenAI.
• Experience working in a global team across multiple time zones.

Working Environment

Choose one of the first two statements below to describe onsite work expectations for the role. Additional points may include travel requirements, office or laboratory working environment, highly collaborative environment, description of equipment used, etc.

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize th