Overview
About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing on areas of greatest potential and developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases. We work with patients, doctors and healthcare professionals to ensure patient and clinical needs guide development at every stage. Our global vision for Patient Centricity is to support innovative health solutions through a deep understanding of the patient experience. Patient Centricity is a guiding principle for action across all staff, roles and divisions.
Opportunity: This role oversees and supports the setup and maintenance of packaging artwork, as well as master data related to materials, customers, suppliers, and associated business units and systems. The main aim is to ensure full alignment with Astellas’ quality expectations, internal procedures, and global regulatory standards. The position primarily supports Quality Assurance activities within Supply Product Development—specifically the Labelling Management Group and Global Financial Solutions—while partnering with various teams across the organisation as needed. Beyond day-to-day responsibilities, this role helps drive operational oversight within the broader CMC Product QA team, including leading management review processes, tracking performance through key metrics, and handling critical quality matters tied to artwork, master records, or product integrity. This role offers hybrid working arrangements in line with Astellas’ Responsible Flexibility Guidelines.
Responsibilities and Accountabilities
* Providing quality oversight and support to key internal departments, including but not limited to SPD, LMG, MDM, GFS, and Regulatory Affairs.
* Managing relevant change control processes with compliance to quality standards, internal policies, and industry GMP/GDP requirements, while ensuring coordination across change types.
* Facilitating the resolution of deviations, non-conformances, and related quality concerns to maintain long-term compliance and safeguard product quality.
* Applying both proactive and reactive risk management to areas of responsibility, identifying and escalating significant compliance risks to line management, and supporting mitigation through corrective and preventive actions.
* Delivering operational governance within the CMC PQA function by liaising with the Global RIM team, supporting the CMO management review process, and overseeing SQI and REC processes, including metrics tracking, procedure upkeep, and senior leadership reporting.
* Coordinating Significant Quality Issue (SQI) activities, including root cause investigations, CAPA implementation, Health Authority notifications, and product recall efforts initiated by the MAH, QA, or regulatory bodies.
* Promoting a culture of quality, compliance, integrity, and continuous improvement by leading by example and maintaining strong relationships with stakeholders.
* Representing QA on cross-functional projects and working groups, acting as a quality advocate and offering clear guidance on compliance expectations.
* Maintaining controlled departmental documents by drafting, updating, and administering Quality Manuals, POLs, SOPs, STLs, and forms as needed.
Essential Knowledge And Experience
* Experience within the pharmaceutical industry.
* Demonstrated expertise in compliance, with the ability to interpret and apply relevant laws and industry regulations.
* Strong written, verbal, and interpersonal communication skills, with proven ability to influence, facilitate discussions, and collaborate effectively across Astellas and with external partners.
* Fluent in English, both written and spoken.
* Capable of working independently, including in ambiguous situations or when managing multiple priorities.
Preferred Experience
* Previous operational experience relating to the management of printed packaging material artwork, master data and/or the maintenance of pharmaceutical Marketing Authorisations and Dossiers.
Education
* BSc Pharmacist, Biology, Chemistry or equivalent.
Working Environment
* This is a permanent full-time position based in the UK or Ireland. This role follows our hybrid working model. Role requires a blend of home and a minimum of 1 day a quarter in our Addlestone office. Flexibility may be required in line with business needs. Candidate 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.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Information Technology
Industries
* Pharmaceutical Manufacturing
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