Quality Partner Germany

UCB S.A.; Monheim am Rhein; Hybrid; EUR 70,000 - 110,000; Full time

Job summary

UCB S.A. in Monheim am Rhein, Germany, seeks a Quality Partner (m/f/d) to strengthen the Distribution & Market Quality team.

In this local, cross-functional role you will ensure the German affiliate Quality Management System complies with GMP and GDP and supports timely quality activities. You will collaborate with Market Quality, Global Quality, Supply Chain, Pharmacovigilance and Regulatory colleagues, oversee vendors and quality agreements, and maintain key documents such as the Site Master

Qualifications

• Bachelor's or Master's degree in a scientific discipline, or equivalent.
• Extensive quality experience within a regulated pharmaceutical environment.
• Strong knowledge of GMP and GDP requirements and compliance processes.
• Strong decision-making skills and ability to work independently.
• Fluent written and spoken German and English.
• Experience supporting deviation management, change controls, CAPA, audits and inspections.
• QP qualification according to §15 AMG would be advantageous.

Responsibilities

• Execute and continuously improve the local Quality Management System.
• Ensure local quality activities align with the UCB global Quality Management System.
• Support deviation management, change controls, CAPA activities, audits, inspections, and self-inspections.
• Oversee local regulated vendors, qualifications, quality agreements, and periodic assessments.
• Maintain quality documentation, including the Site Master File and Quality Manual.
• Provide GMP and GDP quality expertise and escalate significant risks.

Skills

Quality Management

GxP knowledge

Communication skills

Cross-functional collaboration

Education

Bachelor's or Master's in science

Qualified Person (QP) certification (advantage)

Job description

Make your mark for patients

Quality Partner (m/f/d) Germany

To strengthen our Distribution and Market Quality team, we are looking for a Quality Partner (m/f/d) Germany who is collaborative, caring and committed to impact to join our Distribution & Market Quality team, based in our Monheim am Rhein office in Germany.

About the role

In this local, cross-functional role, you will report to the Market Quality Lead and support the team to ensure that the German affiliate Quality Management System work in a way that ensure compliance with company quality standards, procedures, and applicable Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements. You will identify and mitigate quality risks, enable timely delivery of quality activities, and foster continuous improvement across the affiliate.

Who you'll work with

You will collaborate with Market Quality, Global Quality, Supply Chain, Pharmacovigilance, and Regulatory colleagues. You will also work with local GxP vendors supporting regulated activities and other internal and external stakeholders to support compliant operations, inspection readiness, and effective resolution of quality matters.

What you'll do

• Execute and continuously improve the local Quality Management System
• Ensure local quality activities align with the UCB global Quality Management System.
• Support deviation management, change controls, CAPA activities, audits, inspections, and self-inspections.
• Oversee local regulated vendors, qualifications, quality agreements, and periodic assessments.
• Maintain quality documentation, including the Site Master File and Quality Manual.
• Provide GMP and GDP quality expertise and escalte significant risks.

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

• Bachelor's or Master's degree in a scientific discipline, or an equivalent qualification.
• Extensive quality experience within a regulated pharmaceutical environment.
• Strong knowledge of GMP and GDP requirements and compliance processes.
• Strong decision-making skills, the ability to work independently, and a collaborative, patient-focused quality mindset.
• Strong written and verbal communication skills in German and English.
• Experience supporting deviation management, change controls, CAPA activities, audits, and inspections.
• Qualification as a Qualified Person (QP) according to §15 AMG would be considered an advantage.

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.