Manager, Technology and Data QA (Santa Fe)

Manager, Technology and Data QA (Santa Fe)

12 ago
|
Astellas Pharma
|
Santa Fe

12 ago

Astellas Pharma

Santa Fe

Join to apply for the Manager, Technology and Data QA role at Astellas Pharma
This position is based in Mexico City (Santa Fe) and will require on-site work in a hybrid set up.
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 integral 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

📌 Manager, Technology and Data QA (Santa Fe)
🏢 Astellas Pharma
📍 Santa Fe

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