Pv System Process Governance Professional

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’ 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**:
Reporting to the PV System Process Governance (PV SPG) Team Lead, the purpose of this role is to ensure the development, maintenance, and improvement of operational excellence in PV system and business operations globally.

This position is responsible for
- maintenance and improvement of PV IT systems including safety database and process automation solutions supported by new technologies;
- oversight of outsourcing vendor supporting PV IT system operations;
- maintenance of PV IT system management processes;
- representing PV Transformation and Technology (PV T&T) in cross-functional discussion to identify solutions to address new regulatory requirements or process enhancement.

This role is responsible for decisions regarding continues system enhancement requirements, bringing visibility to operational activities and effectiveness (metrics and analytics) and cross-functional process improvement with the objective of streamlining and standardizing the PV system landscape and ensuring the accuracy and reliability of safety information. Liaises with peers across the industry to determine and establish best practice within Astellas.

**Responsibilities and Accountabilities**:

- Translates business requirements that occur in daily operations into system configuration components.
- Represents PV T&T in cross-functional discussion to identify solutions to address new regulatory requirements or process enhancement.
- Ensures that safety database system configurations are compatible with regulatory requirements and corporate strategy.
- Works with Digital X and software vendors to ensure all PV IT systems are operational and compliant with regulatory requirements and company validation policies.
- Oversees the development of Computer System Validation documentations, including Operational Verification Test scripts and Performance Verification test scripts for PV IT systems.
- Maintains the validated status of safety database and associated systems and ensure adequate maintenance of reference data and configurations to support business continuity/risk management.
- Maintains the safety data system to be compliant with the FDA’s Part 11 and related worldwide regulations.
- Responsible for quality investigations / root cause analysis and CAPA management for PV IT systems relevant findings.
- Serves as the primary contact point for regional safety database users and stakeholders within PV.
- Maintains and improves other PV IT systems to continue to meet various regulatory requirements in all countries where Astellas has responsibility.
- Ensures the business objectives of timeliness, accuracy, high quality, integrity, and security of the global safety database, including electronic submissions to regulatory authorities.
- Oversees daily safety database operations, including business configuration changes, development and execution of various outputs, and ensure the quality and timeliness of deliverables in support of business processes and in response to HA questions.
- Assesses the appropriateness and potential impact of safety database change requests to ensure the continued compliance with worldwide regulations, the validity of the database and the quality of outputs.
- Oversees the assessment of impact of system changes on downstream activities and impact of major process changes on safety database platform.
- Oversees global safety database incidents, and address incidents raised by business stakeholders. If needed, works with DigitalX and software vendors to fix issues.
- Ensures Global Safety Database Computer System Validation (CSV) documents are maintained appropriately during safety database change management process.
- Drives process efficiency by supporting implementation of electronic and digital capabilities where possible including PV Process change management/control towards electronic and digital transactions
- Enables compliance in processes and systems with both internal and external procedure and guidelines/legislation
- Measures and e