By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Previa verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo.

OBJECTIVES/PURPOSE

Primary point of contact between Quality and Automation / IT departments / Global Technical functions

Support other departments including QC and Manufacturing to identify technical solutions that address data integrity requirements and provide guidance to final users

Foster digital innovation in regulated processes ensuring alignment with relevant regulations

Provide oversight of GxP computerized system activities and documents to confirm that computerized systems comply with regulatory requirements and Takeda procedures for data integrity and IT/OT compliance, as follows:

Participate in DI Quality Councils, CoP and local Steering Committee

Participate in Change Control assessment, including risk assessment process, as DI/IT/OT expert

Collaborate with Automation and IT departments to identify technical solutions that address data integrity requirements and provide guidance to final users

Support the site Digitalization and Automation projects, including Agile 4.0 initiatives and Quality Roadmap

Support Data Analysis and Data Management initiatives that allow agile management of quality KPI and data

Identify and propose new systems and digital solutions to increase process efficiency and support paperless goals

Support other departments including QC and Manufacturing to develop, execute and improve action plans by providing advice and guidance in the application of best practices

Ensure the application of data integrity principles in GMP processes and act as a Data Integrity Champions to promote quality culture.

Technical/Functional (Line) Expertise

Very strong affinity to computer systems and strong knowledge of the underlying concepts of computer science and multiple certifications preferred

Very strong knowledge on ITIL framework and IT/OT compliance standard

Knowledge of cybersecurity measures would complete the role

Knowledge in data management, restore and recovery processes

Experiences in management and execution of IT processes in regulated environment

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Technical degree preferred in Computer Engineering, IT or equivalent. Mandatory: Studies in Cybersecurity and Data Integrity

At least 5 years of experience in pharmaceutical IT QSY/IT/OT departments

Consolidated skills regarding the ITIL framework, infrastructure management.

Fluent in English and Italian

Preferred knowledge of Power Automate

Leadership

Demonstrates strategic enterprise thinking finding innovative ways to serve patients, and build trust, reputation and business

Focuses on the few priorities and delivers superior results

Elevates the capabilities of the organization for now and the future

Creates the environment that inspires and enables people to move the organization forward

Decision-making and Autonomy

Experience in Data Integrity

Experience in IT/OT environments

Problem solving attitude

Knowledge of GMP regulation

Interaction

Local and Global DD&T and Automation teams, Laboratory contractors and vendors, regulatory authority during audit and other technical functions

Innovation

Very strong affinity to computer systems and strong knowledge of the underlying concepts of computer science

Complexity

Ensure compliance with applicable regulations requirements regarding data integrity

#GMSGQ

#LI-LA1

LocationsITA - Rieti

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time