Head of Quality Digital Industrialization
Il y a 2 mois
**Make your mark for patients**
To strengthen our **Global Quality **department we are looking for a talented individual to fill the position of**:Head of Quality Digital Industrialization** - Braine l’Alleud, Belgium**
**About the role**
The Head of Quality Digital Industrialization is a leadership role that drives the digital transformation of the Global Quality organization. The position ensures alignment and collaboration among internal and external stakeholders to drive the Digital Roadmap of the Global Quality Organization. This involves strategic alignment with UCB’s priorities, managing interdependencies and risks, overseeing the delivery of the digital roadmap as well as the lifecycle management of existing digital solutions like the Veeva Quality platform.
**You will work with**
As the Head of Quality Digital Industrialization, you will work closely with a variety of stakeholders, the overall Global Quality organization, including the Quality Leadership Team to ensure strategic alignment. You will also partner with the Digital Technology organization to ensure delivery and manage interdependencies and risks, and working with the Digital Innovation Quality Lead to align on which proof of concept will warrant further industrialization to maximize impact.. Additionally, you will lead a team of Process Data Owners, the Master Data Quality Lead, and project-specific external resources, while steering the implementation of robust data governance practices to maximize the effective use of data within the organization.
**What you will do**
- Global Quality Digital Roadmap**:Design, drive, monitor implementation, and periodically review the Global Quality Digital roadmap in collaboration with internal and external stakeholders.
- Veeva Quality Module Management: Oversee robust deployment, lifecycle management, and business continuity of the Veeva Quality module, ensuring its constant evolution and strategic value maximization, including necessary data migrations.
- Outsourced Service Model Development: Develop and implement an outsourced service model for operational activities related to the Veeva Quality module’s maintenance and lifecycle management, enabling Process Data Owners to focus on strategic projects.
- Collaboration with Quality Digital Innovation Lead**:Collaborate to ensure clear industrialization framework requirements and align on successful Proof of Concepts for subsequent industrialization and integration into the Digital Roadmap.
- Integration with Governance Processes: Ensure the Global Quality Digital Roadmap is fully integrated within the Global Quality PMO and Quality Risk Management governance processes, and periodically report to the Global Quality Lead team on its evolution.
- KPI Design and Monitoring**:Design, maintain, and monitor KPIs related to the quality, efficiency, and capacity of the activities in scope, including escalation where required.
- Data Governance: Develop a data governance framework to deliver high-quality, reliable, and compliant data that can be leveraged through new technologies.
- Digital Solutions Inventory**:Maintain an inventory of Global Quality-owned digital solutions, ensuring appropriate Process Data Owners are identified and maintaining their solutions adequately.
- Compliance with Quality Systems: Ensure all regulated digital activities comply with UCB Quality System, particularly Computer System Validation and Data Integrity requirements.
- Technology and Best Practices: Stay abreast of digital technology evolutions and external/internal benchmarking to bring innovation and best practices.
- Regulated Operations Monitoring: Ensure regulated (GxP) operations of the team remain in control by monitoring Quality (GxP) Indicators and non-GxP KPIs (Projects, Resources, Budget).
- Audit and Inspection Support: Ensure compliance and support any audits or inspections related to the activities performed.
- Quality operations: Author, review, and/or approve SOPs, Deviations, Complaints, Change Controls, or CAPAs related to the activities performed.
- Team Leadership and Management**:Lead and manage the team, ensuring capacity management, performance, and development, as well as compliance with UCB Quality System and Code of Conduct requirements.
**Interested? For this position you’ll need the following education, experience and skills**
- Master’s degree or equivalent education in a relevant scientific discipline
- 15+ years of experience as a leader in the pharmaceutical industry, with a strong background in GxP
- Fluent in English (both oral and written); proficiency in additional languages is a plus
- Proven track record in leading digital transformation projects
- Excellent communication skills, capable of engaging with various levels across the organization, including those less familiar with digital technologies
- Demonstrated expertise in change management, effectively guiding organizations through transitions and ensuring smooth ad
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