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Global Quality Lead Gcp Auditing
il y a 4 semaines
**Make your mark for patients**
To strengthen our **Quality Auditing & Compliance** department we are looking for a talented person to fill the position of**:Global Quality Lead GCP Auditing & Compliance** - Braine l’Alleud, Belgium**
**About the role**
The Global Quality Lead for GCP Auditing & Compliance will develop and execute a GCP audit strategy, delivering a risk-based audit program to ensure the quality and compliance of UCB's GCP Quality Systems. This role ensures that UCB's clinical trials adhere to regulatory requirements, contractual agreements and UCB’s Global Quality Management System, effectively identifying and mitigating compliance risks.
**You will work with**
The Quality Organization, such as Early & Dev Solutions Quality Management, Quality Systems & Intelligence and other auditing teams within Quality Auditing & Compliance. Moreover, you will collaborate with stakeholders outside the Quality Organization, including Global Clinical Sciences & Operations, Global Clinical Development and Statistical Science & Innovation. Additionally, engagement with International Regulatory Authorities occurs through inspections.
**What you will do**
Internal & External Auditing
- Develop and lead a risk based GCP audit program, assessing UCB’s quality system compliance
- Conduct GCP audits per the annual program, including investigator sites, vendors and systems
- Audit potential new vendors/partners for qualification before contracts
- Prepare, support and follow up on external GCP audits, ensuring they align with UCB processes and standards
- Manage audit findings, responses, and CAPAs in the Audit Management Tool, escalating issues as needed
Drive Insights for UCB through Data
- Ensure timely and accurate audit data entry in the Audit Management Tool
- Collaborate on issuing KPIs and dashboards for trend analysis and risk assessment across the GCP quality system
- Provide data and feedback to internal stakeholders on quality/performance indicators and compliance status
Compliance Issues
- Escalate GCP compliance concerns and provide expert guidance on CAPAs and quality improvements
- Report critical compliance risks/issues to Quality Auditing & Compliance Leadership.
Consulting, Educating, Quality Improvement, and External Focus:
- Leverage Regulatory Surveillance, Indrustry benchmarking, business, regulatory, and quality knowledge to influence quality approaches and ensure compliance with regulatory guidelines and UCB standards
- Participate in medium
- to long-term projects and lead improvement initiatives, including policy creation, training material development, and regulatory surveillance
**Interested? For this position you’ll need the following education, experience and skills**
- Bachelor’s or Master’s degree
- Substantial and broad-ranging experience in the pharmaceutical/biotechnology sector, including significant time in GCP-related areas
- Required experience in Clinical Data Management and/or Biostatistics
- At least 5 years of experience in auditing, and 5 years in clinical roles or a combination of both
- Proven experience in leading a full range of GCP audits for internal processes/units and external partners or vendors
- In-depth knowledge of ICH-GCP, applicable domestic and international regulations, quality principles and relevant business processes
- High personal integrity with a commitment to patient welfare and ethical behavior
- Fluent in English; additional languages are a plus
- Willing to travel nationally and internationally, up to 30% of the time
- Self-starter, reliable, positive, and able to manage workload and priorities effectively
- Confident presenter and communicator, capable of representing the company and delivering clear messages to various audiences
- Skilled negotiator, able to influence and gain cooperation from stakeholders, including senior management, during audits
- Excellent planning and organizational skills with a structured approach
- Builds strong internal and external partnerships
If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.
RANDATUCB
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 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 equitable 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 y
