Qualification Lead

vor 1 Woche

Bulle, Schweiz UCB Vollzeit

**Make your mark for patients**

We are looking for a **Qualification Lead **who is eager to join us in our **Internal Manufacturing** department, based in our manufacturing site in **Bulle**, **Switzerland**.

**About the role**

As a Qualification Lead, you will oversee and ensure the qualification of a new PEG (Polyethylene glycol) production unit in compliance with regulatory standards and user needs. You will lead the Qualification team, integrate activities into the project timeline, and train team members on qualification methodologies.

You will serve as the primary representative for the qualification process during audits and inspections by health authorities and partners.

**What you’ll do***

**Project Management**
- Lead the Qualification team and related activities within the project.
- Ensure that all qualification activities are integrated in the overall project schedule, coordinated efficiently and safely and executed timely.
- Train the project team to the Qualification methodologies as required.
- Oversee timely preparation and adequate resourcing of qualification activities to align with project timelines.
- Proactively manage and escalate issues, proposing mitigation measures as needed.
- Present the qualification process and documentation during inspections and audits by health authorities and partners.

**Qualification**
- Develop and execute the global qualification strategy, including writing plans, protocols, and reports for GMP installations and systems.
- Coordinate qualification activities with external partners, maintaining up-to-date planning and alignment.
- Collaborate with internal stakeholders to ensure smooth integration within the site system.

**Quality**
- Ensure all team members involved in qualification are properly trained, developing training materials as needed.
- Maintain data integrity by using authorized documents, reviewing qualification reports, and managing deviations and Change Controls.
- Represent and present qualification documentation during inspections and audits by health authorities and partners.

**I**nterested? For this role we’re looking for the following** **education, experience** **and **skills***
- Master’s degree.
- 3 years in pharmaceutical and/or biotechnological manufacturing as QA lead or expert.
- In-depth knowledge of cGMPs and regulations linked with chemical/biotech/pharmaceutical manufacturing.
- Participation in projects of construction and qualification of pharma/biotech units or similar projects.
- Strong leadership skills.
- Good level of spoken and written French and English.
- Excellent communication skills, for communicating with internal and external partners.
- Ability to structure ideas quickly and clearly.
- Excellent organization and problem-solving skills.
- Ability to define objectives and how to reach them.
- High capacity to anticipate issues, identify priorities and make decisions.
- High level of autonomy and good stress management skills.
- Solution-oriented and sensitive to customer needs.
- Pragmatic and critical-minded.
- Sense of responsibility and ownership.
- Sense of initiative.
- Team player.

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.

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