Quality Assurance Associate

Quality Assurance Associate

About Astellas:

At Astellas, we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing 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 guide 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 caregivers, ensuring 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 the QA Affiliate, you will independently complete standard quality assurance activities in the affiliate. The position supports the Responsible Person Import (RPi) and the QA Lead to meet his/her Responsibilities and Accountabilities. You will perform and process activities governed by Good Distribution Practice Guidelines (GDP Guidelines) as defined in the (local & global) Quality Management System.

Hybrid Working:

At Astellas, we recognize the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home, optimizing the most productive work environment for you to succeed and deliver.

Key activities for this role:

1. Perform and process activities governed by Good Distribution Practice Guidelines (GDP Guidelines) as defined in the (global) Quality Management System (for example, QA oversight of Product Storage and Distribution, nonconformance management, product complaint handling, change control, supplier management, and annual product review) and implement improvements to correct inefficiencies and non-conformances.
2. Support with inspection management for the wholesale dealer license (or equivalent license), specifically during inspections and recalls.
3. Represent Affiliate QA in recurrent, local, and global project teams, such as workflow training and onboarding training.
4. Act as a role model for the Quality Culture in the affiliate.

Essential Knowledge & Experience:

1. Relevant transferable skills in a comparable role in the pharmaceutical industry (preferred).
2. Understanding of implementation and understanding of GDP, GMP, and Quality Management Systems.
3. Good organizational, coordination, presentation, and communication skills.
4. Experience with Trackwise (Digital), Veeva, and SAP systems (Preferred).
5. Knowledge of handling regulatory interfaces such as inspections and audits (Preferred).
6. Fluent in English.

Education:

1. Degree in a science/health-related subject or equivalent.

Additional information:

1. This is a permanent, full-time position.
2. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

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.