Global Quality Lead GCP Auditing

il y a 3 semaines

Brainel'Alleud, Belgique UCB Temps plein

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 Proficient in applying regulatory requirements for the qualification, validation, implementation, use, and lifecycle management of digital systems, tools and applications 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 .

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 

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