Quality Management System Documentation & Training Specialist

UCB; Bulle; Hybrid; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Hybrid work model (40% office hours)

Zusammenfassung

UCB is seeking a Quality Management System Documentation & Training Specialist to join the QA Compliance Operations team at the Bulle site in Switzerland. The role focuses on maintaining QMS documentation, training processes, and master data while ensuring GMP compliance and driving digital innovations across the organization.

You will lead data-driven improvements, support audits, and collaborate across functions to strengthen quality culture and operational excellence in a hybrid work

Qualifikationen

• Bachelor’s degree or equivalent in a scientific, pharmaceutical, quality, documentation, training, or related field.
• Proven experience driving process improvement, harmonization, digitalization, or transformation initiatives.
• Strong understanding of data integrity principles and quality data management.
• Experience in GMP-regulated pharmaceutical environments.
• Experience managing quality documentation, training systems, and associated data.

Aufgaben

• Drive continuous improvement and harmonization of QMS Documentation and Training processes.
• Lead digital transformation projects in QA documentation management to enable data-driven, paperless workflows.
• Leverage AI-enabled solutions to enhance quality processes and operational performance.
• Monitor and analyze quality data to support data integrity, reporting, and decision-making.
• Support evolution and optimization of QMS processes, systems, and tools.
• Manage QMS documentation, training systems, and master data lifecycle.
• Ensure accuracy, consistency, and archiving of documentation and training records.
• Maintain training matrices, curricula, metadata, and quality records.
• Provide guidance to stakeholders on documentation and training processes.
• Support audits and inspections and promote GMP compliance.
• Contribute to cross-functional projects enhancing quality and operational excellence.

Kenntnisse

Process improvement

Data integrity

Audit readiness

Collaboration

Agility

Continuous improvement

Digitalization

Quality data management

QMS knowledge

Documentation & training guidance

Ausbildung

Bachelor's degree or equivalent (science/quality/training)

Tools

LMS

eDMS

eQMS

Jobbeschreibung

We are looking for a Quality Management System Documentation & Training Specialist, who is eager to join us in our QA Compliance Operations department, based in our manufacturing site in Bulle, Switzerland.

About The Role

As a QMS Doc & Training Specialist, you will play a key role in maintaining, developing, and continuously improving QMS Documentation and Training processes, systems, records, and master data. You will ensure compliance with GMP requirements while contributing to quality excellence, operational performance, and lead digital innovation projects across the organization.

This role is ideal for a Quality professional who is passionate about combining compliance, process optimization, data management, and technology to deliver sustainable improvements and support a strong Quality Culture.

What You’ll Do

• Drive continuous improvement, harmonization, and simplification initiatives across QMS Documentation and Training processes.
• Lead digital transformation projects within QA documentation management, supporting the transition towards more efficient, data-driven, and paperless ways of working.
• Leverage innovative technologies and approved AI-enabled solutions to enhance quality processes and operational performance.
• Monitor, analyze, and maintain quality data to support data integrity, compliance, reporting, and informed decision-making.
• Support the evolution and optimization of Quality Management System (QMS) processes, systems, and tools.
• Contribute to the management ofQMS Documentation and Training systems, records, and master data throughout their lifecycle.
• Ensure accuracy, consistency, compliance, and archiving of documentation and training records.
• Maintain training matrices, curricula, documentation metadata, and quality records.
• Provide guidance and support to stakeholders on documentation and training processes.
• Support audit readiness and participate in internal and external audits and inspections.
• Promote a strong Quality Culture by ensuring compliance with GMP requirements and quality standards.
• Contribute to cross-functional projects that enhance quality, compliance, and operational excellence.

Interested? For this role we’re looking for the followingeducation, experienceand skills

• Bachelor's degree or equivalent experience in a scientific, pharmaceutical, quality, documentation, training, or related field.
• Proven experience driving process improvement, harmonization, digitalization, or transformation initiatives.
• Strong understanding of data integrity principles and quality data management.
• Significant experience within the pharmaceutical industry and a GMP-regulated environment.
• Strong customer focus, collaboration skills, agility, adaptability, and a continuous improvement mindset.
• Strong knowledge of Quality Management Systems (QMS), compliance requirements, and audit readiness.
• Experience managing quality documentation, training systems, and associated data throughout their lifecycle.
• Experience working with QMS platforms such as LMS, eDMS, eQMS, or similar systems.
• Experience supporting audits, inspections, and presenting quality processes in a regulated environment.
• Experience contributing to the development and deployment of digital and AI-enabled solutions in a QA GxP environment, supporting process digitalization and paperless ways of working.
• Fluent French and professional proficiency in English.

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 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 equal 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.

At UCB, we’ve 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 [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.