Head of Global Quality Auditing R&d

Il y a 2 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 R&D and PV** **- Braine l’Alleud, Belgium**

**About the role**

This Quality Leadership role involves formulating and implementing UCB’s Global Quality Auditing strategy within the realms of Good Pharmacovigilance Practices (GVP,) Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). It encompasses the creation, execution, and continuous refinement of risk-based audit programs, designed to ensure stringent compliance of UCB's systems with GVP, GCP and GLP standards globally. The role is providing strategic direction and leadership to our dedicated team of auditors based across all geographies, overseeing all territories where UCB has a footprint, whether directly or via third-party collaborations.

**You will work with**

In this role, the Quality Head will work with an international team of internal and external auditors, overseeing multiple vendors and ensuring compliance with GVP, GCP, and GLP standards. They will collaborate with key internal stakeholders, support Health Authority Inspections, and engage with third-party partners to drive continuous quality improvement across UCB’s global operations.

**What you will do**

Strategic Planning
- Develop and implement comprehensive GVP, GCP & GLP audit strategies that includes a risk-based audit program to ensure the robustness of the UCB’s GVP, GCP & GLP Quality Systems
- 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, 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 the R&D and PV 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
- Ensure enough and appropriate resourcing utilizing both internal and external auditors.

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, GCP & GLP quality systems.

Compliance Oversight and Quality Improvement
- Identify and escalate GVP, 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 GVP, GCP & GLP compliance consulting and education to ensure that the UCB network remains current with regulatory and industry trends
- 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 to maintain expert awareness of current regulatory thinking, trends, and benchmarking through key regulatory and industry relationships
- Foster a learning, agile, and progressive culture to work efficiently and pragmatically and promote digital innovation.

Management and Leadership
- Lead and develop the team to achieve objectives and enhance auditor capabilities
- Manage budgets and resources in line with UCB strategy
- Promote a culture of risk management and continuous improvement

**Interested? For this position you’ll need the following education, experience and skills**
- A master’s degree is required, ideally in a relevant field such as pharmaceutical sciences, biotechnology, chemistry, or a related discipline
- Proficiency in English is mandatory, with excellent communication skills required for effective interaction at all levels.
- 10 years of experience in the pharmaceutical industry within regulated areas (e.g., Research, Laboratory, Clinical, Pharmacovigilance, Manufacturing,) and/or Quality Assurance expertise.
- In depth knowledge and understanding of the complexity of the BioPharma business, including drug development process and post-marketing obligations, GXP principles and digital trends.
- Previous experience as GxP Audito

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