Quality Affiliate Manager
Il y a 6 mois
**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 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 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.
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.
Work Location: Hybrid remote in 1800 Vilvoorde
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