Global Quality Lead Auditing Technology

Make your mark for patients

To strengthen ourGlobal Quality Auditingdepartment we are looking for a talented profile to fill the position of:Global Quality Lead Technology Auditing Bulle Switzerland.

About the role

The Global Quality Lead Technology Auditing role requires a highly skilled professional specializing in audits of Computer Systems Validation (CSV) IT compliance and Data Integrity within the biotech and pharmaceutical industry. The ideal candidate will have a strong background in GxP-regulated environments demonstrate deep knowledge of FDA EMA and other global regulatory requirements and ensure that computerized systems meet the highest standards of compliance security and quality. They identify and mitigate compliance risks through global auditing setting quality standards monitoring regulatory trends and educating teams. Effective communication and organizational skills are essential for identifying gaps assessing risks and aligning stakeholders and senior management on potential issues. The role is based in the EU and will require on average 30-35% travel on a global basis.

You will work with

This role will work closely with the Head of Quality Auditing and Supply and Technical Solutions as well as collaborating 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 risk mitigation strategies.

What you will do

Internal & External Auditing/Inspections

• Support the creation and maintenance of the Technology Global Audit Program leveraging a risk-based approach for ranking and prioritization
• Support the Technology Global Audit Program through the execution of Due Diligence Qualification Routine 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
• Build data & digital competency for the UCB auditors across GxP disciplines by providing dedicated training feedback and creation of training material.
• Support the development and execution of the Auditor Qualification Program

Consulting Educating Quality Improvement 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
• Function as an in-house Consultant and Educator to 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 youll need the following education experience and skills

• Masters or Bachelors degree in a relevant scientific discipline (Computer Science Bioinformatics Engineering or related science)
• Fluent in English (speaking & writing); additional languages are a plus
• Minimum 5-10 years of experience in software development lifecycle computerized systems validation or equivalent role within a GxP-regulated environment
• Willing to travel internationally up to 35% of the time
• Strong understanding of FDA EMA GxP GDPR and other relevant regulatory frameworks.
• Proven experience providing quality oversight for laboratory systems IT systems and QMS platforms ensuring validation activities comply with regulatory requirements and internal policies.
• Demonstrated ability to establish and maintain governance frameworks for validation lifecycle management including system risk assessments validation planning and execution testing and periodic reviews.
• Firsthand experience developing and implementing strategies for computer systems validation ensuring alignment with industry standards regulatory expectations and company procedures.
• Strong background in Data Integrity compliance including application of ALCOA principles across computerized systems and supporting remediation activities.
• Experience leading and managing CAPA processes from initiation through closure ensuring timely and effective resolution.
• Proven history in inspection readiness activities including preparation for regulatory audits and internal inspections.
• Familiarity with IT best practices IT Security and compliance with GDPR regulations.
• In-depth understanding of Quality Systems as they relate to GxP activities and computerized systems.
• Ability to interpret and apply regulatory requirements to complex IT and validation scenarios.
• Excellent leadership communication and collaboration skills to work effectively across functional teams.
• Knowledge of 21 CFR Part 11 Annex 11 GAMP 5 and other electronic records/electronic signatures regulations.
• Certification in CSV Data Integrity IT or Auditing is a plus.

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 over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent 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 equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats 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.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

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