Head of Global Quality Auditing Gcp

il y a 1 mois

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **Global Quality Assurance **department, we are looking for a talented profile to fill the position of**:Head of Global Quality Auditing GCP & GLP - Braine l’Alleud, Belgium**

**About the role**

This Quality Leadership role at UCB involves developing and implementing a global quality auditing strategy for Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). It includes creating and refining risk-based audit programs to ensure compliance with GCP and GLP standards worldwide. The role provides strategic direction to a team of auditors across all UCB territories, whether directly or through third-party collaborations. Key responsibilities include leading and developing an international team of auditors, overseeing multiple auditing vendors, supporting Health Authority Inspections in preclinical and clinical areas, staying updated on legislative changes, and fostering partnerships with internal stakeholders. Insights from audits and inspections are used for quality improvement and risk mitigation.

**You will work with**

For this role, you will work with a variety of professionals and teams. You will lead and develop an international team of internal quality auditors, ensuring they adhere to the global quality auditing strategy. You will also collaborate with multiple auditing vendors to manage their performance and compliance. Additionally, you will support Health Authority Inspections in preclinical and clinical areas, working closely with regulatory bodies. Building strong partnerships with key internal stakeholders across different departments is crucial, as these collaborations will help drive quality improvements and risk mitigation based on insights from audits and inspections.

**What you will do**

Strategic Planning
- Develop and implement comprehensive GCP & GLP audit strategies that includes a risk-based audit program to ensure the robustness of the UCB’s GCP & GLP Quality Systems
- Define, own, and refine UCB’s risk-based auditing strategy for UCB R&D operations globally
- Create and maintain the global audit program leveraging a risk-based approach for ranking and prioritization to generate an annual audit plan.

Audit Execution
- Ensure regular GCP & GLP audits as outlined in the annual programs are conducted. These audits should encompass internal sites, vendors, systems, and potential new partners to ensure compliance and identify areas for improvement
- Drive and contribute personally to the R&D global audit program through the execution of Routine, and for Cause audits, as well as Qualification audits
- Ensure Due Diligence audits are conducted, as and when required, in accordance with UCB’s strategy to enrich pipeline and portfolio by bringing new assets into existing and new populations
- Oversee and optimize external contracts and vendors to align with UCB goals and objectives and maintain positive partnerships.

Audit Findings Management
- Manage all audit findings, responses, and Corrective and Preventive Actions (CAPAs) using an Audit Management Tool and escalate issues as necessary.

Data Management and Performance Tracking
- Ensure accurate and timely audit data entry in the Audit Management Tool, issue Key Performance Indicators (KPIs) and dashboards for trend analysis and risk assessment across the GCP & GLP quality systems.

Compliance Oversight and Quality Improvement
- Identify and escalate GCP & GLP compliance and data integrity concerns. Provide expert guidance on CAPAs and quality improvements and report compliance risks or issues to senior leadership

Consultation and Education
- Use Regulatory Intelligence, Industry benchmarking, and knowledge of business, regulatory, and quality standards to influence quality approaches and ensure compliance
- Provide GCP & GLP compliance consulting and education to ensure that the UCB network remains current with regulatory and industry trends
- Collaborate with and influence key stakeholders within UCB to collectively drive quality across the organization
- Lead or contribute to global quality projects and initiatives and promote internal and external collaboration to adopt new and enhance existing digital solutions
- Represent UCB at Industry Associations as needed and participate as relevant to expert working groups on topics associated with UCB endeavors
- Cultivate internal and external network in order to maintain expert awareness of current regulatory thinking, trends, and benchmarking through key regulatory and industry relationships

Management and Leadership
- Organize and balance the team to achieve set objectives efficiently
- Recruit and build a team of auditors, ensuring their capabilities align with UCB’s strategic goals
- Partner with other departments to foster the development of technical and organizational expertise within the team
- Forecast and manage the department’s budget to ensure effective resource allocation
- Cultivate an environment

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