Qualification Lead

Make your mark for patients

We are looking for a Sterility Qualification Lead who is eager to be part of our Qualification team, based in our biotechnological, pharmaceutical and chemical production site in Bulle, Switzerland.

About the role

As the Sterility Qualification Lead, you will be responsible for ensuring the qualification of installations and systems in accordance with procedures, regulatory requirements, and user needs. You will provide expertise in qualification during investigations, Change Controls, and projects. You will present the qualification process and documentation during inspections and audits by health authorities and partners.

Additionally, you will act as an expert, supporting the management of the Qualification Specialists' team, and be recognized as a Subject Matter Expert (SME) for major and strategic projects. This role requires a strategic thinker with strong leadership skills and a deep understanding of equipment qualification and technologies.

What you'll do

• Develop and implement comprehensive qualification strategies for different projects, compliant with industry standards and regulations.
• Act as a point of reference and support qualification specialists (both internal and external) in their activities.
• Be responsible for good qualification practices on the production site and suggest improvements in line with changing regulatory requirements.
• Ensure the coordination of qualification activities with internal & external partners.
• Participate in technical or organizational cross-functional projects as well as in specific manufacturing projects for activities related to qualification.
• Participate to deviations and Change Controls as SME for qualification related subjects,
• Present the qualification documentation during inspections and audits by health authorities and partners.

Interested? For this role we're looking for the following education, experience and skills

• Engineering or master's degree in Life Science
• In-depth knowledge of cGMPs and regulations linked with biotech/pharmaceutical manufacturing.
• More than 5 years in pharmaceutical and/or biotechnological manufacturing.
• More than 5 years in qualification of installations/systems.
• Previous experience in qualification of complex analytical equipment & biotechnology manufacturing equipment is a plus.
• Strong leadership skills.
• High level of organization and autonomy.
• Excellent communication skills, with the ability to engage effectively at all levels of the organization and work collaboratively within a team.
• Strong problem-solving abilities, with a proactive approach to identifying challenges and implementing effective solutions.
• High capacity to anticipate issues, identify priorities and make decisions.
• RA/QA expertise.
• Good level of spoken and written French and 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 EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.