Bio DS Quality DI CS Manager — Data Integrity Lead

UCB; Eigenbrakel; Hybride; EUR 90 000 - 130 000; Plein temps

Résumé du poste

UCB in Belgium is seeking a Bio DS Quality CS Manager at Braine l'Alleud to lead QA activities related to Data Integrity within the Bio DS facility. You will drive DI compliance, oversee the CSQA team, and partner with Production, Automation, IT and CSV QA to ensure DI standards are met.

The role requires steering DI initiatives during ramp-up, coaching teams, and ensuring systems comply with data lifecycle requirements.

Qualifications

• Master’s degree in a scientific discipline aligned to pharmaceutical sciences.
• Minimum 7 years in the pharmaceutical industry with DI exposure.
• Fluent English and French, written and spoken.
• Experience with regulatory DI requirements and GxP systems.

Responsabilités

• Act as DI SME to ensure data lifecycle compliance and data security.
• Lead and coach the CSQA team responsible for Data Integrity.
• Collaborate with Production, Automation, IT and QA to ensure DI requirements.
• Manage deviations, CAPA and change controls for computerized systems.
• Oversee audit trails, access management reviews, and DI risk assessments.

Connaissances

English/French communication

ALCOA++ / GAMP5

MES / DCS (Siemens PCS7)

Data Integrity awareness

Change control / CAPA

Formation

Master’s degree in a relevant scientific discipline

Outils

Siemens PCS7

Description du poste

UCB in Belgium is seeking a Bio DS Quality CS Manager at Braine l'Alleud to lead QA activities related to Data Integrity within the Bio DS facility. You will drive DI compliance, oversee the CSQA team, and partner with Production, Automation, IT and CSV QA to ensure DI standards are met.

The role requires steering DI initiatives during ramp-up, coaching teams, and ensuring systems comply with data lifecycle requirements.