Gbl Quality Audit Outsourcg R&d Lead

Il y a 4 mois

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **Quality Auditing & Compliance department** we are looking for a talented profile to fill the position of**:Global Quality Auditing Outsourcing R&D Lead **- Braine l’Alleud, Belgium**

**About the role**

The Global Quality Auditing Outsourcing R&D Lead develops and implements GCP and GLP audit strategies, including a risk-based audit program to ensure UCB's GCP/GLP Quality Systems meet regulatory requirements, contractual obligations, and UCB's Global Quality Management System. This role involves identifying and mitigating compliance risks associated with UCB’s clinical trials.

Additionally, the Lead provides expert input on GCP/GLP processes, aligning with global and local regulations and industry best practices. They stay updated on global regulatory trends through engagement with industry forums and associations.

**You will work with**

To ensure a comprehensive end-to-end approach, close collaboration is essential across various domains. Within the Quality Organization, this includes partnering with teams such as Early & R&D Quality Management, Quality Systems & Intelligence, and other auditing teams within Global Quality Auditing. Externally, it involves working closely with stakeholders including Global Clinical Sciences & Operations, Global Clinical Development, Statistical Science & Innovation, and the Rare Disease Organization. Additionally, engaging with international regulatory authorities during inspections is crucial to maintain compliance and uphold standards.

**What you will do**

External Auditing Vendor Management
- Support vendor management for R&D audits and ensure regulatory compliance.
- Define, evaluate, and monitor KPIs and KQIs for R&D auditing vendors, driving continuous improvement.
- Review and approve auditing documents and oversee R&D audits performed by external vendors, ensuring alignment with UCB standards.
- Provide management with summaries and analyses of quality risks and outcomes related to vendor activities.

External Auditing
- Contribute to the development of the risk-based GLP/GCP audit program, evaluating UCB’s quality system.
- Conduct GCP/GLP audits according to the annual audit program and for vendor qualifications.
- Manage audit findings, responses, and CAPAs in the Audit Management Tool, escalating concerns as needed.
- Support preparation and follow-up for critical regulatory inspections in collaboration with the R&D and PV Quality team.

Drive Insights for UCB through Data
- Ensure accurate and timely input of audit data into the Audit Management Tool.
- Provide data and feedback on quality indicators and compliance status to internal stakeholders (e.g., Global Clinical Science, Development Rare Disease).

Compliance Issues
- Escalate GCP/GLP compliance concerns and provide guidance for CAPAs and quality improvements.
- Report critical compliance risks to Global Quality Auditing Leadership.

Consulting, Educating, Quality Improvement, and External Focus
- Engage in medium
- to long-term projects and perform additional tasks as requested by Global Quality Auditing Leadership.

**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
- Auditor Certification is a as sciences Certification/Registration Preferred (e.g. medical, pharmacy, Bio-Engineering, and/or Microbiological,
- Extensive experience in the pharmaceutical/biotechnology sector, particularly in GCP/GLP areas.
- Minimum of 3 years leading GCP audits for internal and external processes, with strong quality management understanding.
- At least 5 years in research and development, with experience in GLP/GCLP-related areas.
- Experience in vendor management is big plus
- Fluent English communication (oral and written); additional languages are a plus.
- Skilled in fostering a quality culture through inspiring, motivating, and coaching others, while promoting knowledge sharing.
- Proficient in using electronic systems in regulated environments, with strong computer literacy.
- Demonstrates high personal integrity, commitment to patient welfare, and ethical behavior; fluent in English with additional languages a plus.
- Capable of national and international travel (20% of the time), and excels in self-management, planning, and organizing tasks.
- Effective communicator and negotiator, able to influence stakeholders, manage risks, and handle stressful situations while evaluating and improving quality management systems.

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 around 8,500 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

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