Senior Trial Master File Compliance Manager

Description Senior Trial Master File Compliance ManagerAbout 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 care-givers, 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. The Opportunity : As a Senior Trial Master File Compliance Manager, you will take a strategic view to ensure consistent, inspection-ready TMF compliance across clinical programs and portfolios. This role oversees TMF governance, quality oversight, and operational excellence, ensuring alignment with global regulatory requirements, the TMF Reference Model, and internal standards. The Senior Manager partners with Clinical Operations, Quality Assurance, Records Management, and external partners (e.g., CROs, vendors) to drive TMF process improvements, lead audit and inspection readiness activities, and monitor performance metrics across studies. The role includes mentoring TMF compliance staff, leading cross-functional working groups, and influencing enterprise-wide TMF initiatives such as technology enhancements, SOP development, and training frameworks. You will act as a key escalation point for TMF-related compliance issues and plays a critical role in shaping and maintaining a high-quality TMF environment that supports the integrity of clinical trial documentation and regulatory submission readiness. 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. Key Responsibilities :

• Support and lead inspection readiness, audit support, and other compliance related topics for Clinical Operations.
• Develops standards and training materials related to TMF compliance.
• Oversees scheduling and management of compliance checks, while providing guidance to other TMF Compliance Managers.
• Supports study teams in training / guidance on TMF requirements & processes. A “go to” resource for teams to solve study specific TMF questions and queries.
• Actively reviews TMF Health data analytics, identifying gaps / issues & developing solutions to resolve in a timely manner. Escalates issues to functional leadership, TMF governance, and QA as needed to ensure TMF quality and team performance.
• Works with TMF MO, TMF Governance, & TMF Champions to identify training and oversight needs. Supports inspection readiness and preparation activities.
• Maintain TMF processes in line with the TMF Reference Model, HA guidance and industry standards.

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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. #LI-Warsaw #LI-Hybrid #LI-LL1