Quality Affiliate Manager
About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About This Job:
As the Quality Assurance (QA) manager you will be the primary contact for quality issues in the assigned country (Belgium). You will contribute to and execute QA goals aligned with our 5-year strategic plan. Responsibilities include fostering communication within the Affiliate, collaborating with global/regional QA colleagues, and managing relationships with external entities. You will take the role of GDP Responsible Person, ensuring compliance in all QA activities, and maintaining an independent role in decision-making within the Affiliate.
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 Responsibilities:
- Act as a local Responsible Person as defined in European Good Distribution Practice (GDP) Guideline 2013/C 343/01.
- Maintain and continuously improve the local Quality Management System
- Act as the local QA lead and direct contact for all (product) quality issues, including internal and GMP/GDP audits, escalation of significant events, recall operations and other QA lead-specific matters.
- Contribute to the development and execution of Local Affiliate QA objectives and Global QA plans.
Essential Skills & Knowledge:
- Proven experience in quality management within a pharmaceutical company.
- Strong skills in planning and execution.
- In-depth knowledge of local and EU GDP guidelines.
- Proven ability to develop and maintain effective relationship with external bodies including national competent authorities and local vendors like third party logistics (3PL).
- Experience in conducting audits and oversight of suppliers and internal processes.
- Fluent in spoken and written Dutch, French, and English as a prerequisite.
Preferred Skills & Knowledge:
- Pharmacy degree or equivalent per local RP requirement (Royal Decree 14 December 2006).
Additional information:
- This is a permanent, full-time position.
- This position is based in Belgium.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in our Brussels 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.