Manager, Quality Assurance, Clinical QA
About Astellas:
At Astellas, experience is coupled energised with a relentless challenger spirit.
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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.
The Opportunity:
As the Manager, Quality Assurance, Clinical QA, you will collaborate closely with Medical and Development (M&D) and other business units to support global and local drug development, registration, and marketing efforts across various Therapeutic Areas (TAs) and all stages of drug development. You will work alongside QA members and M&D teams to ensure alignment with company-wide standards and Quality Systems. Your role involves ensuring Quality oversight of M&D processes and clinical trials (Phase I-IV) to maintain compliance with international Good Clinical Practice (GCP) standards and other relevant regulations. Additionally, you will be responsible for managing, conducting, and participating in regional and global audits, managing external QA resources under the guidance of senior CQA staff, and providing technical expertise to identify and resolve quality issues.
Hybrid Working:
At Astellas we recognise 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; optimising the most productive work environment for you to succeed and deliver.
Responsibilities:
Essential Knowledge & Experience:
Education:
Additional information:
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.
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