Head of Global Quality Auditing GVP

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:

1. Develop and implement comprehensive GVP audit strategies that include a risk-based audit program to ensure the robustness of UCB’s GVP Quality Systems and compliance with REMS FDA commitments.
2. Define, own, and refine UCB’s risk-based auditing strategy for UCB Pharmacovigilance (PV) and REMS related operations globally.
3. Create and maintain the global audit program leveraging a risk-based approach for ranking and prioritization to generate an annual audit plan.

Audit Execution:

1. Ensure regular GVP & REMS audits as outlined in the annual programs are conducted, encompassing internal sites, vendors, systems, and potential new partners to ensure compliance and identify areas for improvement.
2. 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.
3. Ensure Due Diligence audits are conducted as required, in accordance with UCB’s strategy to enrich pipeline and portfolio by bringing new assets into existing and new populations.
4. Oversee and optimize external contracts and vendors to align with UCB goals and objectives and maintain positive partnerships.

Audit Findings Management:

1. 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:

1. 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:

1. 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:

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

Management and Leadership:

1. Structure and balance the team to effectively achieve set objectives.
2. Recruit, develop and collaborate to ensure auditor capabilities align with UCB’s strategic goals.
3. Promote the growth of technical and organizational expertise within the team.
4. Accurately forecast and manage the department’s budget to ensure optimal resource allocation.
5. Foster a culture that embraces risk-taking and change management principles to drive continuous improvement and adaptability.

Interested? For this position you’ll need the following education, experience and skills

1. Bachelor’s, master’s degree or an education in a relevant scientific discipline.
2. 10 years of experience in the pharmaceutical industry within regulated areas (e.g., Research, Laboratory, Clinical, Pharmacovigilance, Manufacturing, …) and/or Quality Assurance expertise.
3. 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.
4. Access to or direct expert knowledge of worldwide regulations, principles and theories pertaining to Quality Assurance and substantial practical experience of their application in complex situations.
5. Previous experience as Auditor.
6. Experience with Audit Management Tools, Controlled Document Management Systems, Regulated Databases is advantageous.
7. Able to inspire confidence and trust at all levels through excellent communication (English) and influencing skills, understanding of corporate and interdepartmental dynamics and technical ability.
8. Foster a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others both within and outside the team.
9. Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management.
10. Moral courage with deep commitment to the welfare of patients, quality, integrity and reliability.
11. Demonstrated self-starter, highly reliable, with positive, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by senior management and willingness to accept responsibility.
12. Ability to evaluate quality management systems and quality operations independently and critically in support of Quality culture and operational output, balancing weaknesses against requirements and expectations.
13. Excellent judgment, able to leverage knowledge to assess complex and critical processes, systems, and problems, remove obstacles, and to identify/devise novel strategies and innovative solutions that are proportionate to the risk.
14. Travel nationally and internationally as business necessitates, 30% of time on average.

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 you can grow, and have the freedom to carve your own career path to achieve your full potential.

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.