Head of Global Quality Auditing Gvp

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 GVP - Braine l’Alleud, Belgium**

**About the role**

This Quality Leadership role at UCB involves developing and implementing a global quality auditing strategy for Good Pharmacovigilance Practices (GVP) and ensuring compliance with Risk Evaluation and Mitigation Strategies (REMS) FDA commitments. It includes creating and refining risk-based audit programs to maintain stringent GVP 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 pharmacovigilance areas, staying updated on legislative changes, and fostering strong partnerships with internal stakeholders. Insights from audits and inspections are used for quality improvement and risk mitigation.

**You will work with**

In this Quality Leadership role at UCB, you will collaborate with a diverse group of professionals and teams. You will lead and develop an international team of internal and external quality auditors, ensuring they adhere to the global quality auditing strategy. You will also work closely with multiple auditing vendors to manage their performance and compliance. Additionally, you will support Health Authority Inspections in pharmacovigilance areas, engaging with regulatory bodies to ensure standards are met. Building strong partnerships with key internal stakeholders across various departments is essential, 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 GVP audit strategies that includes a risk-based audit program to ensure the robustness of the UCB’s GVP Quality Systems and compliance with REMS FDA commitments
- Define, own, and refine UCB’s risk-based auditing strategy for UCB Pharmacovigilance (PV) and REMS related 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 GVP & REMS 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 PV & REMS 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 GVP quality system.

Compliance Oversight and Quality Improvement:

- Identify and escalate GVP & REMS 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 GVP 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
- Structure and balance the team to effectively achieve set objectives
- Recruit, develop and collaborate to ensure auditor capabilities align with UCB’s strategic goals
- Promote the growth of technical and organizati

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