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. Process and Standards Lead 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. 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. Required Experience 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. Quality & Risk Management 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, ensuring successful readiness and driving a Culture of Quality. Providing hands‑on support during audits and inspections, facilitating and coordinating communication and responses. Supporting the MA Quality & Risk Management group with Non‑Conformance Management, as applicable. Preferred Experience Proven experience in the pharmaceutical industry or management consulting, focusing on Quality Management and/or leading Strategic Initiatives. Solid understanding of Medical Affairs best practices. Strong working knowledge of ICH/GCP, FDA/EMEA regulations, and document management standards. Experienced in managing multiple strategic and tactical projects with a focus on operational and continuous improvement. Track record of driving optimisation and quality initiatives across functions, influencing multiple departments and leadership levels. Skilled problem solver, anticipating and resolving issues proactively. Able to translate solutions into sustainable global action plans through strong stakeholder collaboration. Demonstrated leadership in a matrix environment, inspiring and motivating teams. Excellent English communication skills — verbal, written, and presentation. Highly organised with the ability to prioritise and deliver across multiple projects. Effective working independently and collaboratively across global teams, regions, and cultures. Education Bachelor’s degree or equivalent in science or health‑related field required or an advanced degree in Business Administration. Demonstrable experience in applying Agile methodology. Demonstrable management experience, including mentoring employees within the department and other functional areas, as appropriate. Relevant process improvement methodology training (e.g. ASQ certification, PRINCE, PMP certification). Additional Information The is a permanent full‑time position based in the UK. This position follows our hybrid working model. Role requires a blend of home and minimum of 1 day a quarter in 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. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. Seniority level Mid‑Senior level Employment type Full‑time Job function Management and Manufacturing Industries Pharmaceutical Manufacturing #J-18808-Ljbffr