Manager, Quality Assurance, Governance
Description
Building your career at Astellas continues to offer inspiring challenges and a chance to make your mark in doing good for others.
Our open and progressive culture is what makes us Astellas. It is a culture of doing good for others and contributing to a sustainable society.
Reporting to Head, Quality Assurance, Governance, the Quality Assurance, Governance Manager is responsible for the development and maintenance of excellence in activities supporting QA effectiveness and efficiency, by assisting in developing and maintaining systems, tools and templates, reporting QA activities, measuring QA progress and output, supporting QA staff in Inspection readiness activities and management of Regulatory Agency Inspections.
Join us in this dynamic role and contribute to our team's success at Astellas. Apply now to be part of this exciting journey.
About This Job
- Assists in managing the global electronic Quality Management System (eQMS) solution (e.g., TrackWise Digital), including user access, trouble shooting, Change Management, validation testing and creation of reports for the generation of metrics.
- Ensures training compliance for employees and contractors requesting eQMS application access by creating and submitting required learning management forms and monitoring for applicable training curricula completion before granting system user access.
- Organizes and maintains collective knowledge related to the Management Review process and the eQMS by design and maintenance of a common knowledge sharing location (such as SPS) and manages content and user access.
- Assists in development and implementation of tools, processes, and methodologies to monitor progress against QA objectives and strategies and develops methods to gather and collate information for status reports to QA Senior Management.
- Supports and occasionally leads the implementation of assigned QA and Quality Systems strategies and process improvement projects which contribute to QA compliance, efficiency, and effectiveness.
- Provides support for Regulatory Agency inspections when requests are made of the Quality Governance team.
- Knowledge of Software Development Lifecycle (SDLC) and Computer System Validation (CSV) as it applies to QA.
- Acts as a backup for other roles in the Quality Governance team.
Essential Knowledge & Experience
- Bachelor’s Degree required (Life Science preferred)
- Minimum 3 years of experience in pharmaceutical, biotechnology, or related industry.
- Minimum of 2 years significant experience in a Quality organization and/or minimum of 2 years project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.
- Strong understanding of pharmaceutical and medical device regulations for both marketed and investigational products, and excellent knowledge of global health authorities.
- Proficiency in Microsoft Office, including Microsoft Teams and SharePoint.
- Affinity with IT systems related to quality management systems and automated generation of dashboards or metrics.
Preferred Knowledge & Experience
- Experience working with TrackWise Digital and QlikView software.
