Specialist, Ethics & Compliance Risk Excellence Program Operations

About This Role

This role supports the daily operations of Astellas' global Ethics & Compliance (E&C) hub, ensuring consistent and high-quality processes for managing issues, planned exceptions, and complaints. The specialist will work with E&C colleagues and business stakeholders globally to assess incoming matters, coordinate actions, provide reporting, and continuously improve the E&C program's operations.

Responsibilities

• Manage the day-to-day operations of the global E&C system hub for issues, planned exceptions, and complaints
• Review incoming cases, ensure good data quality, and support their assessment and triage
• Coordinate and follow up on Corrective and Preventive Actions (CAPAs), ensuring actions progress and issues are closed appropriately
• Work closely with E&C, Risk Assurance, and business stakeholders globally to assess issues and recommend next steps
• Support dashboards, reporting, and insights that help E&C leadership understand key risks and trends
• Respond to questions from E&C colleagues and provide guidance and training on using the central hub and related processes
• Support E&C training activities, including training administration and assignment through the Learning Management System
• Identify opportunities to simplify processes, improve operational efficiency, and strengthen the E&C program
• Take ownership of assigned activities, manage priorities, and ensure high-quality delivery within agreed deadlines

Requirements

• Experience within the pharmaceutical, biopharmaceutical, or closely related healthcare industry
• Relevant experience in Ethics & Compliance, risk, governance, controls, assurance, finance, commercial operations, or another pharma business function with exposure to compliance requirements
• Strong analytical and critical-thinking skills, with the ability to assess information and make sound recommendations
• Strong organization and follow-through, with the ability to manage multiple activities and priorities independently
• Confidence working and communicating with stakeholders in a global, multicultural environment
• Excellent written and spoken English

Nice to have:

• Experience in Ethics & Compliance or Healthcare Compliance within the pharmaceutical industry
• Knowledge of pharmaceutical industry regulations, codes, and compliance requirements, including interactions with healthcare professionals and organizations
• Experience managing compliance issues, CAPAs, monitoring findings, exceptions, or similar processes
• Experience with compliance, quality, or case-management systems, such as eQMS
• Experience with dashboards, reporting, data analysis, or generating insights for leadership