Job Title

Manager, Quality Document ManagementAbout Astellas:At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional business results.Everyone at Astellas has a responsibility for creating a brighter future for patients around the world.From the first moment, Astellas will inspire you to put this ethos into practice – with a positive, agile company culture and with well-defined ethical principles, values, and systems.Purpose & Scope:Support QA Document Records Program : Help set up and manage a Quality Assurance (QA) document records program.This involves systematically assessing, reviewing, controlling, distributing, retaining, and archiving records from customers and stakeholders.Manage QA Document Life Cycle : Identify and support processes for managing the lifecycle of QA documents and records.This includes tracking system administration, filing, archiving, and retention.Ensure Regulatory Compliance : Ensure that all documents and their retention meet global regulatory requirements, such as cGMP, GLP, GCP, and electronic records and signatures.Lead QA Improvements : Lead continuous improvement projects for QA documentation processes that may impact multiple departments.Responsibilities and Accountabilities:Administers the document control program within QA, which includes establishing metrics (applying trends) for customer and quality optimization.Interacts cross functionally with peers and management staff to effectively make decisions regarding document management and review.Delegates and sets priorities, with the manager's guidance, based upon criticality and importance within the department and as part of the company's overall directive.Maintains a central repository for all QA controlled documentation and coordinates processes for documents received from internal customers, Astellas entities and external companies.Performs quality risk assessment and ensures compliance with established retention schedules.Supports the managing, assigning, and prioritizing the document distribution activities to the appropriate QA personnel.Creates procedures required for the documentation processes within QA to ensure compliance with global and regulatory standards for a modern quality system.Supports the establishment and determination of record retention for QA documents/records, ensuring compliance with established regulations and procedures.Facilitates the effective processing of all critical QA documents/records to ensure they are maintained in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body.Assures compliance with SOPs and regulatory requirements.Utilizes technical skills and tools to effectively identify issues, evaluate risk and facilitate appropriate solutions to management.Collaborates with cross functional departments and external entities to ensure proper tracking, review and approval of quality documents.Trends and generates Quality metrics for QA Management review.Effectively researches and supports continuous improvement in QA processes or systems related to document management and which can impact other departments.Conducts orientation and in-house, site-specific training on Quality documentation SOPs and relevant QA systems/ processes.Develops, maintains, and deliver training materials.QA notification and enhancements of the department's knowledge of quality systems and strategies.Supports the establishment/implementation of Quality system documents and regional quality standards, as needed.Performs other duties as assigned or special projects as needed.Required QualificationsBachelor's degree or equivalent with 3 years of industry experience.Must demonstrate effective communication, writing and interpersonal skills and the ability to interface across multiple departments and external stakeholders.Detailed knowledge of GXP regulations, other quality principles and applies current interpretations/trends to Quality documentation and record control.Ability to generate SOPs related to critical QA processes.Must demonstrate ability to manage projects independently, with limited management oversight.Working EnvironmentThis position is based in Mexico and will require on-site work (Hybrid).At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.We believe this will optimize the most productive work environment for all employees to succeed and deliver.Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.