Global Quality Lead Auditing GMP

Make your mark for patients

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

About The Role

The Global Quality Lead Auditing GMP ensures UCB’s Pharma, Bio, Gene Therapy and Medical Device activities comply with current GMP/GDP standards and internal policies. They identify and mitigate compliance risks through global auditing, setting quality standards, monitoring regulatory trends and educating teams. Strong communication and organizational skills are essential for identifying gaps, assessing risks, and aligning stakeholders and senior management on potential issues.

You will work with

This profile will work closely with the Head of Quality - Auditing and Compliance Supply and Technical Solutions, as well as collaborate with internal teams across Pharma, Bio, Gene Therapy, and Medical Device divisions. They will also engage with external auditors and regulatory bodies to ensure compliance. Additionally, the role involves frequent interaction with stakeholders and senior management to address compliance risks and align on risk mitigation strategies.

What You Will Do

Internal & External Auditing/Inspections

• Support the creation and maintenance of the Global Audit Program, leveraging a risk-based approach for ranking and prioritization,
• Support the Global Audit Program through the execution of Due Diligence, Qualification, Routine GMP/GDP and For Cause audits including Mock Inspection exercises, Pre-approval or Routine inspection assistance as assigned per senior management,
• Ensure the follow up on the above-mentioned audits or inspections, as well as timely CAPA closure, including continuous improvement related to Quality Auditing metrics,
• Support the development and execution of the Auditor Qualification Program

Consulting, Educating and External Focus

• Provide Technical and Compliance guidance as a member of selected committees,
• Lead improvement initiatives, identified by Senior Management, in-order to improve Corporate QA processes and effectiveness,
• Partner with the UCB Network QA operational teams to prepare sites for pre-approval and/or routine regulatory inspections, as deemed necessary and which may include on-site or remote inspection support activities and/or training,
• Keep abreast of regulatory and industry trends: Share key information gathered via professional associations and regulators (upcoming regulations, best practices) across the UCB network and ensure they feed into Quality Standards.

Compliance Issues

• Partner with colleagues/others to identify and mitigate Compliance risks, resolve potential regulatory observations,
• Escalate as identified any critical Compliance or Patient Safety risks to upper management,
• Leverage internal resources and SME network to develop appropriate action plans and decisions as needed

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

• Master’s degree or bachelor’s degree, certified Auditor or Quality Professional (e.g., ASQ) – certifications are preferred but not required
• Fluent in English (speaking & writing); additional languages are a plus
• Minimum 10 years of experience in Quality Assurance, focused on Biopharmaceuticals/Advanced Therapies
• Deep expertise in Drug Substance and/or Drug Product manufacturing for pharma/biopharma drugs
• Preferred knowledge/experience in Combination Product and Device QMS and regulatory frameworks
• Aseptic Processing/Sterile Manufacturing/Gene Therapy/Advanced Therapy expertise is preferred
• Extensive auditing experience, either as Auditor or Auditee
• Strong asset: Experience in regulatory inspections (FDA, ANVISA, KFDA, EMA, etc.)
• Comfortable with new technologies beyond basic IT tools (e.g., Office, Veeva), including virtual/augmented reality, AI, etc.
• Proficient in Audit Management Tools (e.g., TrackWise, Veeva)
• Excellent presentation, training, analytical, and investigation skills
• Willingness to travel globally up to 30-35%
• Analytical mindset to understand complex global Compliance and Regulatory issues
• Strong negotiation skills with proven ability to influence within a global matrix organization
• Excellent planning, organizational skills, and ability to prioritize based on Compliance and Patient Safety risks
• Effective in handling stressful situations, driving issue resolution, and escalating critical issues to Senior Management when needed

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.