Global Quality Lead Auditing GPVP

Make your mark for patients

To strengthen our Quality Assurance department we are looking for a talented profile to fill the position of: Global Quality Lead Auditing GPVP – Braine l’Alleud, Belgium

About The Role

The Global Quality Lead for Pharmacovigilance collaborates in developing and executing a strategy that includes a risk-based audit program to ensure the quality and compliance of UCB’s Pharmacovigilance Systems. This role also involves providing guidance and recommendations on processes affected by Good Pharmacovigilance Practice (GVP), adhering to global and local regulations, guidelines, and industry best practices. Additionally, the individual liaises directly with Regulatory Authorities worldwide during inspections of the Pharmacovigilance System.

You will work with

The Global Quality Lead GPVP will work closely with various stakeholders, including internal teams, external partners, and regulatory authorities. This profile will lead and participate in audits of critical processes, affiliates, and vendors, and will be responsible for preparing and hosting regulatory inspections.

What You Will Do

• Execute (plan, conduct, report) the Pharmacovigilance audit program (including audits of Critical Processes, Affiliates, Licensing Partners, Service Providers/Vendors) in support of clinical safety and Pharmacovigilance activities related to UCB products
• Perform qualification PV audits of potential new vendors/partners/ Specialty Pharmacies (SPs), Specialty Distributors (SDs)
• Proactively manage audit findings, responses, and CAPAs in the Audit Management Tool, ensuring prompt mitigation of deficiencies and escalating concerns to senior management as needed.
• Lead or contribute to developing the risk-based PV audit program by evaluating UCB’s clinical safety and Pharmacovigilance quality system and its compliance
• Lead the preparation, hosting and follow up of Critical Regulatory Authority inspections related to clinical safety and Pharmacovigilance activities at the Central sites, and Affiliates as deemed necessary and practicable
• Contribute data and feedback to Patient Safety and other functional groups relating to Key Quality/Performance Indicators and quality compliance status
• Collaborate with external auditors and/or vendors as required, ensuring that findings from pharmacovigilance audits are distributed, and responses and CAPAs are tracked and followed up as necessary in the Audit Management Tool
• Participate in medium-long term projects within competence.
• Upon the request of/with the approval of the Head Global auditing R&D and PVperform other tasks within competence (as determined by relevant training, experience and/or qualifications).

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

• Bachelor’s, master’s degree or an education in a relevant scientific discipline (Computer Science, Bioinformatics, Engineering or related science).
• Fluent English communication (oral and written); additional languages are a plus.
• Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in Pharmacovigilance-related areas
• Experience in leading full range of Pharmacovigilance audits for internal processes/units and external partners or vendors, and in managing/hosting regulatory inspections or third-party audits with depth of understanding of the theory and practice of quality management
• Minimum of 5 years auditing, 5 years Pharmacovigilance and/or a combination of the two
• In depth knowledge and understanding of Pharmacovigilance systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GVP principles, and practice
• Familiarity with Computerize System Validation (CSV) activities
• Familiarity with statistical principles and data analysis
• Effective verbal and written communication skills and capacity of adapting communication style to different audiences and cultures
• Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others
• High level of personal integrity with a strong commitment to patient welfare and ethical behavior
• Strong presentation, training, interpersonal, negotiation, and organizational skills
• Capable of national and international travel (30% of the time), confident presentation skills, and skilled in negotiation and risk management

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.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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