Title:  Manager, Technology and Data QA

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

Purpose and Scope

• Responsible for managing and executing the Technology and Data Quality Assurance (TDQA) audit and validation oversight programs related to regional Astellas Information Systems processes for computer systems, technology solutions, clinical and commercial systems, data integrity processes, and related process improvement initiatives within QA.
• Provides operational management to drive consistent cGxP compliance and validation approaches to ensure compliance with Astellas standards, policies, and procedures.
• Ensures compliance with global Electronic Records / Electronic signatures regulations and related cGxP regulatory requirements.
• Responsible for managing the TDQA audit program related to audits of vendors, service providers, and internal processes in support of computerized system validations for new system implementations, system upgrades, change controls, and periodic reviews for computer systems.
• Develops, facilitates, and implements process improvements and supports new technology initiatives as Astellas continually invests in new technology solutions and computerized systems.
• Contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5 year strategic plan.

Role and Responsibilities

• Responsible for operationally managing, coordinating, planning, and administering the TDQA program to oversee the computerized systems validation program, and ensuring reviews of computerized system validation documentation is completed to ensure compliance with Astellas policies and procedures. Reports status of validation projects to management.
• Responsible for operational management, planning, and administration of the TDQA internal and vendor audit program related to computer software providers and computer related service providers utilized by Astellas. Responsible for scheduling and performing audits. Manages internal and external resources to perform audits. Reports status of audit program to management. Generates trend reports of audit findings for management reviews.
• Assists TDQA management to plan and manage internal and external resources to execute the TDQA validation oversight and audit programs. Interacts with functional teams to assist QA management to identify QA activities and resources necessary for review and support of project related initiatives. Manage programs and resources necessary to support assigned projects.
• Identifies, develops, facilitates, and manages process improvement initiatives related to electronic system development life cycles, validation processes, IT systems/processes, data integrity control processes, and regulatory compliance assurance processes throughout Astellas. Manages multiple projects concurrently. Collaborates with key stakeholders and functional area customers across the Astellas organization for process improvement initiatives.
• Serves as QA representative on assigned project teams associated with software validation projects and process improvement initiatives to provide guidance, direction, and support regarding quality assurance and regulatory compliance, to resolve compliance issues, report to management, and to ensure completion of quality related action items.

Role and Responsibilities (continue)

• Ensures and facilitates compliance with global Electronic Records / Electronic signatures regulations (e.g. 21 CFR Part 11). Provides quality and compliance guidance in areas of continuous improvement, innovation, and validation. Collaborates, advises and provides consultation on quality matters to individuals, study/core teams, and functional management teams across the Astellas organization.
• Assists management for development, coaching, mentoring and support for TDQA resources. Develops staff to serve as QA representatives on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items.
• Manages QA oversight of validation projects related to specific products to assure quality of output as well as compliance with standards, policies, procedures and regulations. Assists QA management to assess and ensure regulatory inspection readiness. Supports management in presenting and defending validation strategies during regulatory authority and 3rd party inspections.
• Develops tools to track and trend compliance metrics, validation activities and issues; and assures that Astellas systems and procedures comply with internal company (global, regional, and site) and external regulatory agency standards for compliance and validation.
• Participates in the development of a comprehensive risk management process related to computerized systems validation activities within Astellas.
• Authors, revises, and performs maintenance and administration of departmental quality documents (i.e., policies, SOPs, WPDs/WIs, STLs, etc.) as necessary. Conducts and coordinates validation, compliance, and quality training as needed.

Experience & Qualifications

• Bachelor of Arts/ Bachelor of Science degree or equivalent science related
• Minimum of 8 years experience in quality assurance in the pharmaceutical industry
• Minimum 5 years experience performing or overseeing in software/system development life cycle and computer system validation.
• Minimum of 5 years project management experience, preferably in a multicultural, global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.
• Proficiency in Microsoft Office
• Domestic and international travel of 15-20% may be required

Location

This position is based in Mexico City (Santa Fe) and will require on-site work in a hybrid set up.