About this opportunity
Make your mark for patients
To strengthen our Bio DS Quality we are looking for a talented profile to fill the position of: CSQA and Data Integrity Specialist – Braine l’Alleud, Belgium.
About the role
The CSQA and Data Integrity Specialist will 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. The BIO DS CS Specialist will report to the BIO DS CS Manager.
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
The BIO DS CS Specialist will collaborate closely with cross-functional teams including Production, BioProcess Engineering, Automation, IT, IT Compliance, CSV QA, and Quality stakeholders. Through these partnerships, the specialist 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
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 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.
Act as back-up of Data Integrity and CSQA manager.
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 3 years’ experience in the pharmaceutical industry.
Fluent English 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.
Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.
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, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application.
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 EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Requisition ID: 93821
Recruiter: Hiba Loutfi
Hiring Manager: Clélia Soulard
Talent Partner: Sandrine Eelbo
Job Level: SA II
Please consult HRAnswers for more information on job levels.
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