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About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed.
Role overview
As a Quality Intelligence Associate, you will play a vital role in supporting Astellas’ global Quality Assurance (QA) organization by maintaining the Astellas Quality Intelligence Program (AQuIP). Your work will contribute to inspection readiness, regulatory compliance, and informed decision-making across the business. You will collaborate with stakeholders across the enterprise to deliver timely regulatory insights, manage the AQuIP SharePoint site, and support quality strategy execution. You will be responsible for curating and communicating intelligence that can impact the Astellas Quality Management System (QMS), supporting both compliance and continuous improvement.
Hybrid working
At Astellas we recognize balance between professional and home life. We support a hybrid approach which provides flexibility on whether to work from home or in the office.
Key Activities For This Role
- Perform daily monitoring and updates of the AQuIP SharePoint site, including sourcing, posting, and maintaining relevant Quality Intelligence (QI) content.
- Conduct regular internet surveillance to identify regulatory intelligence relevant to Astellas operations, supporting inspection readiness and proactive compliance.
- Lead the Regulatory Intelligence Review Committee (RIRC) to review and assess QI for potential impact on the QMS and ensure appropriate escalation or action.
- Collaborate with stakeholders and Subject Matter Experts (SMEs) to assess QI impact, manage review status, and track required documentation updates.
- Support the preparation of quality data for management review by consolidating and analyzing QI trends and generating reports and presentations.
Essential Knowledge & Experience
- Initial experience in pharmaceutical, biotechnology, or a related industry
- Initial experience in a Quality function and/or project management within a global or matrixed organization.
- Foundational knowledge of pharmaceutical and/or medical device regulations across major health authorities (e.g., FDA, EMA, PMDA).
- Proficient with Microsoft Office tools, especially SharePoint, Excel, PowerPoint, and Microsoft Teams.
- Strong communication and organizational skills with the ability to manage multiple priorities and deliver timely, accurate insights.
Preferred Qualifications
- Experience supporting quality systems, inspection readiness, or regulatory intelligence processes.
- Familiarity with SharePoint Online content management, including creating pages and updating site content.
- Ability to interpret regulatory intelligence and link it to internal quality system impacts and compliance risks.
- Interest in quality innovation, process improvement, and enabling smarter decision-making within Quality Assurance.
Education/Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or equivalent.
- Demonstrated ability to analyze data, generate reports, and communicate insights to a diverse stakeholder group.
- Experience working in a fast-paced, highly regulated, and globally distributed organization.
- Strong facilitation and collaboration skills with a detail-oriented, proactive working style.
- Passion for compliance, continuous improvement, and supporting a robust global Quality culture.
Additional Information
- This is a permanent, full-time position.
- This position is based in Warsaw (Poland).
- 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 need. Candidates must be located within a commutable distance of the office.
Notice
Astellas’ Global Capability Centres (GCCs) are located in India, Poland and Mexico and are integral to our strategic priorities and growth. 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.
Seniority level
Employment type
Job function
- Quality Assurance
- Industries
- Pharmaceutical Manufacturing
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