Manager, Pre-Clinical Quality Audits
Astellas

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

Universal Cells, a subsidiary of Astellas located in Seattle, WA, is focused on development and commercialization of stem cell and regenerative medicine therapies. The location of this position is based in Seattle, Washington, this can be a 50% hybrid (remote-onsite) position.

Purpose and Scope:

Responsible for development and maintenance of operational excellence in Research QA (RQA) activities for Astellas sponsored programs. Reports to Director of RQA, Manager of RQA is a member of the US-RQA Team and contributes to the development, implementation and successful execution of the RQA mission, objectives and 3-5 years strategic plan.

The scope of this position is to manage and provide quality oversight for nonclinical studies (pharmacology/pharmacokinetics/toxicology studies) and clinical bioanalysis for regulatory submission that are executed in compliance with international and local regulatory standards including but not limited to Good Laboratory Practice, (GLP), Good Clinical Practice (GCP), JRS (Japanese Reliability Standard) and other relevant regulations.

Essential Job Responsibilities:

• Lead and conduct internal audits including writing audit reports, writing observations, and follow-through of observation resolution. This includes Independently performing in-phase audits of non-clinical studies as well as study-specific data audits and reports
• Participate in the evaluation and qualification of Nonclinical service providers (new qualification, re-evaluation,)
• Independently plan, perform and/or oversee study-specific external audits according to an audit plan, applicable regulations and procedures
• Author or revise SOPs to address gaps or necessary improvements to Quality Systems and Data Integrity
• Participate in corrective and preventive action teams, assist with investigation, and root cause analysis and verify that actions are implemented and effective
• Work closely with cross functional teams independently for routine compliance and quality guidance
• Assist with the organization, preparation, coordination, and documentation of regulatory inspections
• Conduct risk assessments for assigned area
• Archives relevant departmental documents as per regulatory requirements; assists with archiving of study documentation
• Supporting achievements of departmental goals

Quantitative Dimensions:

• Managing audit programs which approximately contain between 10-15 audits annually and focus on Nonclinical activities, depending on the complexity
• Approximately 50% of time is spent in audit role and an equal amount in the consultancy role and other QA related activities
• Supports regulatory agency inspections of Nonclinical activities and inspection readiness activities with an average of 2 inspections/annum

Organizational Context:

• Reports to the Director of Research QA
• Coordinates QA audit process or activities with RQA management and members
• Interaction with departmental staff, e.g. Japan-RQA and QA- counterparts in other cross functions; direct line management in QA, Test Facility Management, functional peer groups (colleagues involved with SOP writing, Central Archiving, and Training Function), relevant staff of Nonclinical-supporting Departments and Vendors/CRO