Process and Standards Lead

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 caregivers, 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.

Ready to make an impact? In this role, you’ll lead regional and global process improvement initiatives that shape how Quality Procedures and Operating Models run across VALUE Delivery teams. You’ll keep standards sharp, ensure audit and inspection readiness, and champion a culture built on quality. Working with cross‑functional teams, you’ll drive new business processes and continuous improvement projects that deliver real results — boosting agility, performance, and the way we work.

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.

• Collaborating with SMEs across VALUE Delivery to identify, initiate, and lead continuous/process improvement initiatives addressing operational gaps or introducing innovation, positioning VALUE Delivery as an industry‑leading organisation.
• Stewarding the framework through which standards are established and maintained, collaborating with SMEs to drive process simplification, creating clear and accessible procedures that deliver high‑quality outcomes and foster a culture of compliance.
• Serving as project manager for VALUE Delivery Strategic Initiatives by applying AGILE methodology, embedding agile ways of working across VALUE Delivery.
• Creating associated charters, project plans, and process maps supporting delivery of continuous/process improvement projects.
• Drafting and managing delivery of associated Quality Documents (QDs) and/or guidance documents, enabling effective implementation of new ways of working.
• Leading process effectiveness and efficiency checks, measuring and monitoring existing processes, developing improvement measures, and implementing desired process changes to close identified gaps.
• Serving as change agent and expert, leading the organisation through change, ensuring adherence to new or modified processes while maintaining business continuity.
• Monitoring and influencing industry trends and best practices, identifying improvement opportunities, and proposing practical solutions.
• Driving a strong culture of ethics and compliance, leading by example, and challenging non‑compliance appropriately.

• Serving as first point of contact for regional and VALUE Delivery‑focused internal and external audits and inspections.
• Proactively informing VALUE Delivery Leadership of relevant audit planning activities.
• Supporting the MA Quality & Risk Management group in implementing audit and inspection readiness activities,…