Quality Assurance Lead
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.
The Opportunity:
Acting as Responsible Person for Astellas Pharma Europe Ltd, your role will be to ensure all transactional procurement and supply activities of active substances and finished medicinal products are conducted in accordance with the applicable regulations. Establish cross-functional partnerships to ensure compliance with GDP requirements. The successful person will be Eligible to act as Responsible Person according to Article 79 (b) of Directive 2001/83/EC, EU GDP (2013/C 343/01) and Regulation 45 (1) of The Human Medicines Regulations (2012/1916). and manage the maintenance of the appropriate licenses to trade medicinal products for this entity.
Hybrid Working:
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Key activities for this role:
- Ensures full compliance with relevant regulation(s) related to the following financial transactions i.e. buy medicinal products from Astellas plants and from external suppliers, sell medicinal products to Astellas EMEA Affiliates/Trading Parties and other Astellas regions, sell medicinal products to external clients/licensees on behalf of Astellas, in order to ensure continuity of medicinal products.
- Performs and records all activities that are governed by Good Distribution Practice (GDP) Guidelines and ensuring compliance with Astellas Policies.
- Supports with inspection management for the Wholesale Distribution Authorisations license.
- Collaborates with global cross-functional departments to ensure compliance with quality requirements of relevant regulatory authorities.
- Embeds a Compliance Culture across the APEL Trading Party business ensuring Integrity in Action is actively applied in all initiatives.
- Reviews the local QA Manual / SOPs and updates them in alignment with the GDP and Astellas requirements.
- Ensures that an adequate quality management system in full alignment with Astellas’ corporate quality system is established and maintained.
- Working with suppliers and customers are appropriately qualified and demonstrate that they hold the appropriate authorisations and licenses in relation to wholesaling. Ensures review mechanism is in place to verify such qualifications are current.
Essential Knowledge & Experience:
- In-depth experience of implementing and understanding of GDP, GMP and Quality Management Systems
- Relevant external pharmaceutical training, e.g. against the UK gold standard “responsible person medicinal products".
- Appropriate knowledge of financial transactions in relation to product type acquired through previous experience.
- Ability to contribute/lead to local and global impact projects, such as product launches.
- Knowledge of IT systems: Trackwise Digital, Veeva, SAP would be desirable
- Ability to develop and maintain effective relationships with internal and external stakeholders including Astellas global entities.
- Experience in supporting regulatory interfaces such as inspections and audits.
- Experience in GMP/GDP auditing.
Education:
- Bachelor’s degree in a science related field or equivalent
- Eligibility to act as Responsible Person according to Article 79 (b) of Directive 2001/83/EC, EU GDP (2013/C 343/01) and Regulation 45 (1) of The Human Medicines Regulations (2012/1916).
Additional information:
- This is a permanent full-time position.
- English conversational and business English
- This position follows our hybrid working model. Role requires a blend of home and minimum [1] days per quarter in our Addlestone office. Flexibility may be required in line with business need. 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, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.