Head Qualification, Validation, Digital and Data Integrity (Switzerland)

Make your mark for patients

To strengthen ourGlobal QA Compliance Operationsdepartment part of Internal Manufacturing Quality (IMQ) we are looking for a talented profile to fill the position of:Head Qualification Validation Digital and Data Integrity Switzerland Bulle

About the role

The Head of Head Qualification Validation Digital and Data Integrity is a senior position within the Quality Compliance Operations team reporting directly to the Head of QA Compliance Operations.

The position focus will be to ensure strategic oversight harmonization and continuous improvement of Qualification and Validation activities across all internal manufacturing sites; the coordination of Data Integrity Roadmap execution and monitoring; and align with processes being followed also by the External Manufacturing organization.

This strategic role ensures that Qualification Validation Digital and Data Integrity systems across all UCB operational sites are designed implemented and maintained in a harmonized and consistent manner in alignment with the evolving regulatory requirements and internal company standards

While executing these Global activities the role needs to foster a culture of continuous improvement process optimalization driving operational excellence and implement process and value driven Digitalization and collaborate with key stakeholders globally across UCB Units to uphold and enhance the organizations quality standards.

You will work with

In this role you will work closely with various stakeholders across UCBs internal and external manufacturing organizations. You will collaborate with the Internal Manufacturing Quality Assurance Leadership team the QA Compliance Operations Leadership team ensuring alignment and harmonization of Qualification Validation Digital and DI activities across all operational sites. Additionally you will engage with the External Manufacturing organization to align processes. You will also interact with key stakeholders globally across UCB Units to foster a culture of continuous improvement process optimization and wherever there is a process and value driven digitalization opportunity while supporting the organizations quality standards.

What you will do

• Lead a global quality team who supports operational and strategic activities provide development opportunities while being value driven.
• Conduct Gemba sessions across UCB Sites/ Departments to understand existing quality processes part of the role and systems identify inefficiencies and identify Value Digitalization when needed.
• Oversee Computerized Systems Validation (CSV) and champion DI initiatives ensuring compliance with global DI standards and best practices of industry.
• Oversee automation projects to optimize manufacturing quality executions.
• Ensure quality oversight across IM including deviations related to qualification validation and testing executed.
• Coordinate the Data Integrity Roadmap execution covering both paper documentation and systems.

• Drive harmonization and standardization of quality practices related to Qualification/ Validation DI execution (DIRA audit trail) across IM sites fostering consistency and compliance globally.

• Support quality improvement programs or/and initiatives aiming at enhancing efficiency reducing risks and maintaining high standards of compliance.
• Support audit and inspection readiness when required ensuring sites are prepared for internal and external reviews.
• Promote a culture of innovation and continuous learning within the team and across the organization.

• Oversee the training matrix onboarding and development of people within the team.

• Serve as the transversal IMQ Single Point Of Contact (SPOC) for Quality Compliance topics below:

• CSV Testing and Access management
• Data Integrity (DIRA audit trail...)
• Cleaning Validation disinfectant Validation
• Qualification management (IQ OQ PQ)
• Utilities facilities
• Maintenance & Metrology

• Partner with key stakeholders to ensure alignment on quality processes and build regular networking communication (e.g. monthly meeting monthly gemba...).
• Integrate any new IM UCB site into the Qualification Validation Digital and Data Integrity framework by defining and executing a comprehensive strategy.

Interested For this position youll need the following education experience and skills

• Bachelors masters degree or an education in a relevant scientific discipline
• Minimum of 10 years in Quality Assurance or/and Quality Systems Operations or/and Quality Compliance within a regulated pharmaceutical environment or equivalent
• Fluent English communication (oral and written); any additional languages are a plus
• Deep understanding of cGMP principles and global regulatory environments
• Proven track record in leading a team of people across the world
• Experience in participating in audits and inspections (FDA)
• Experience in Value driven Digitalization is a plus
• PMO green belt lean & six sigma is a plus
• Excellent organizational and analytical abilities to manage projects
• Expertise in data integrity computerized systems validation and process automation.
• Expertise with quality processes: maintenance & metrology utilities facilities qualification (IQ OQ PQ) cleaning validation disinfectant validation
• Exceptional communication and interpersonal skills for effective stakeholder engagement
• Strategic & Critical thinking with the ability to foster a culture of Quality Continuous Improvement and Innovation

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.