Bio DS Quality CS Manager

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

To strengthen our Bio DS Quality we are looking for a talented profile to fill the position of: Bio DS Quality CS Manager - Braine l'Alleud, Belgium.

About The Role

You will lead and oversee all quality assurance activities related to Data Integrity and activities managed by IT and/or automation teams within UCB’s new commercial biologicals drug substance facility at our Braine campus. You will be also the point of contact for all data integrity topics for the Bio DS Facility.

This role is crucial in ensuring compliance with regulatory and internal standards, contributing to the reliable supply of drug substances. As this is a quite new facility, the role requires actively leading and coaching the production and automation team through the ramp-up phase, adapting to the challenges and realities of the initial years of operation.

You will work with

You will collaborate closely with cross-functional teams including Production, BioProcess Engineering, Automation, IT, IT Compliance, CSV QA, and Quality stakeholders. Through these partnerships, you will support Data Integrity compliance, computerized systems oversight, operational excellence, and digital transformation initiatives across the Bio DS facility.

What You Will Do

• Act as a DI Subject Matter Expert (SME) to meet DI requirements in routine activities and in projects or change controls aimed at improving DI compliance at B7 level. Responsible for ensuring systems comply with data life cycle requirements from initial data creation/recording to archival and decommissioning (data in motion / data at rest). This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability, process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails
• You will manage the team of CSQA responsible for the Data Integrity
• Collaborate with multidisciplinary teams to ensure that GxP data is generated and managed in accordance with DI requirements.
• Implement DI program as defined for the B7 building according to corporate standards and local procedures. Share recommendations or opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.
• Responsible for appropriate management of deviations, CAPA and change controls related to computerized systems and Data Integrity scope.
• Ensure that employees on Bio DS plant are trained and aware of DI requirements. Set up shopfloor session to verify DI principles are in place in use.
• Provide accurate and timely review and approval of report of routine audit trail review, yearly report for access management.
• Support (in collaboration with identified stakeholders (PDO, ITSO, IT compliance, Automation SME) DI Risk Assessments (DIRA) for new and existing (electronic) systems that generate and store GxP data. Ensure harmonization of between all DIRA. Support mitigation and remediation when data integrity gaps are identified.
• Bring support and approval during audit trail review risk assessment (ATR RA) execution .
• Support periodic review of computerised systems in collaboration with CSV QA Specialists and other stakeholders. Provide data to CSV QA to perform periodic review on time.
• Review and approve relevant SOPs: Management of access and software of computerized systems including stand alone systems
• Propose new initiatives and improve existing applications and processes.
• Collaborate with other teams (BioProcess Engineering and Automation) to support digital and automation improvements for manufacturing or supportive activities.
• Provide support during regulatory and internal inspection activities as needed.
• Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS.
• Ensure a safe and healthy work environment.

Interested? For this position you’ll need the following education, experience and skills

• Master’s degree or an education in a relevant scientific discipline
• Minimum of 7 years’ experience in the pharmaceutical industry.
• Fluent English & French communication (oral and written); any additional languages are a plus .
• Must be familiar with the ALCOA++ principles / GAMP5 and their application
• Complete routine tasks with little to no supervision; Confident in making decisions in their subject matter area; Able to work proactively and identify opportunities for improvement
• Demonstrated experience in manufacturing execution system MES and distributed control system DCS (preferably Siemens PCS7).
• Demonstrated experience in biological drug substance (business and/or quality) to facilitate interactions with other teams.
• Ability to face unstable environment and demonstrate agility to handle unpredicted changes.
• Able to remain effective and maintain sound judgment under pressure.

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About Us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.