Global Quality Auditor GCP

Make your mark for patients

To strengthen our Global Quality Auditing department, we are looking for a talented profile to fill the position of: Global Quality Auditor GCP – Braine l’Alleud, Belgium

About the role

The Global Quality Auditor GCP is an experimented profile responsible for ensuring GCP compliance across UCB’s clinical activities. You will plan and conduct audits of sites, CROs, laboratories, vendors and internal systems, while also overseeing outsourced audits to ensure alignment with UCB standards. You will support regulatory inspections, manage audit findings and CAPAs, and provide expert GCP guidance to internal teams. By analyzing audit data and contributing to quality improvements, this role helps maintain the integrity and compliance of UCB’s global clinical operations.

You will work with

As a Global Quality Auditor GCP you will collaborate with a broad network of teams and partners. Internally, you will work closely with Global Clinical Operations, Clinical Development, R&D Quality Management and the wider GXP Global Quality Auditing group, including outsourcing partners and senior QA leadership. Externally, you will interact with investigator sites, CROs and a variety of GCP vendors and external auditors, as well as health authorities during inspections. These collaborations ensure consistent GCP compliance, effective audit execution, and strong quality oversight across UCB’s global clinical activities.

What you will do

Internal & External Auditing/Inspections

• Lead and/or participate in the development of the risk based GC(L)P audit program through evaluation of elements of the UCB quality system and their effect on the overall state of compliance of the system
• Perform GC(L)P audits as per annual audit program including for cause audits (investigator sites, vendors, systems according to established audit strategy)
• Perform GC(L)P audits of potential new vendors/partners for purposes of qualification prior to contractual relationships
• Perform due diligence GCP audits of potential company or asset acquisitions, as required
• Prepare, support and follow-up on GC(L)P audits
• Proactively manage audit findings and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.

Drive Insights for UCB through Data

• Ensure timely and accurate input of audit and inspection data in Audit Management Tool
• Contribute data and feedback to GCP-relevant internal stakeholders in UCB (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status.

Compliance Issues

• Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP compliance issues to support the development and implementation of necessary CAPAs and quality improvement measures.
• Contribute to escalation committee meetings and investigations for potential critical findings

Consulting, Educating, Quality Improvement, and External Focus

• Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH- GCP, other applicable regulatory requirements and UCB global quality standards
• Lead improvement initiatives, and where relevant, create and own the supporting UCB Policies and standards, oversee their deployment including training material development

Strategic Planning

• Support preparation of the GC(L)P Global Quality Auditing program; Investigator/phase 1 Site, GCP vendor and internal system/process audits.

Audit Execution

• Perform audit activities across all audit process stages, from audit announcement to CAPA closure
• Perform all GC(L)P-audit types, including joint GXP (GLP, GPV, IVD/MD/Technology) audits with UCB- or outsourced auditors.

Consultation and Education

• Provide GCP & GCLP compliance consulting and education
• Sharing audit expertise for all GQA audit types with the Global Quality Auditing Team, including the Audit Outsourcing Management Team

Project Management

• According to the prioritization in alignment with objectives, strategy, and resources allocation for project management activities within GQA; lead, drive or participate to projects within or outside GQA/Quality

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

• Bachelor’s/Master’s degree or an education in a relevant scientific discipline
• Minimum of 7 years’ auditing experience (10 years preferred), covering not only investigator-site audits but also vendor- and internal process/system audits
• In-depth knowledge and understanding of GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques
• Possessing knowledge and experience in auditing central laboratories is considered a valuable asset.
• Fluent English communication (oral and written); any additional languages are a plus.
• Familiarity with statistical principles and data analysis
• Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others
• Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
• Able to travel nationally and internationally as business necessitates, 30% of time on average
• Demonstrated self-starter, highly reliable, with positive, action oriented, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility
• Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process
• Ability to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations.
• Ability to cope with stressful situations and drive issue resolution and decisions.
• Demonstrates strong planning and organisational abilities with a systematic approach
• Ability to apply change management principles and practices, to promote an environment of effective people engagement and efficient transition/adoption of changes

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!