Quality Intelligence Associate
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
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.
Sitting within the QA function, 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 that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have 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.
Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centre’s (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 behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, 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.
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