Specialist, Ethics & Compliance Risk Excellence Program Operations

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. Learn more at Astellas.com .

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.

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

Location and Working Environment

This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office

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 the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose & Scope

• Support the day-to-day operation of the global Ethics & Compliance (E&C) hub, managing issues, planned exceptions and complaints and helping ensure consistent, high-quality processes.
• Work with E&C colleagues and business stakeholders across the globe to assess incoming matters, coordinate actions, provide reporting and continuously improve the way the E&C program operates.

Role and 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.

Required Qualifications

• 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 organisation 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.

Preferred Qualifications

• 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 organisations.
• 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.
• Degree in law, life sciences, pharmacy, corporate governance, compliance, finance or another relevant field.

Benefits

Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Learn more at Astellas.com

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.

Our Organisational Values and Behaviours

Accountability

Courage

Impact

Innovation

Integrity

One Astellas

Outcome Focus

Sense of Urgency