Internal Operations Quality Partner

UCB; Eigenbrakel; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

UCB is seeking an Internal Operations Quality Partner for its Belgium site. The role supports GMP compliant manufacturing activities for biological development projects, partnering with the Internal Bio Clin Manufacturing Team to uphold quality across development and clinical supplies.

The candidate will review batch records, release materials for clinical trials, drive QA improvements, and manage change controls. On-site presence is required ~60%, with on-call duties rotating weekends/holidays.

Qualifications

• Minimum of 5 years’ experience in GMP environment.
• Fluent English communication (oral and written); any additional languages are a plus
• Solid understanding of the pharmaceutical biologics sector and relevant technical elements
• Experience with quality systems such as deviations, CAPA, Change Controls
• Ability to interpret current regulations and requirements in product development context
• Excellent communication with stakeholders and ability to work independently
• Must be able to act in most circumstances without direct supervision and handle complex/urgent situations
• On-site presence required (60%)
• Perform on-call duties during weekends and public holidays on a rotating basis
• Experience with laboratory compliance and supplier qualification is an asset

Responsibilities

• Work closely with the Internal Bio Clin Manufacturing Team to ensure the Quality Management System supports product development and clinical supplies
• Ensure QA review of master and executed batch records for drug substance supporting clinical trials
• Review specifications and release materials used in production of drug substance for clinical trials
• Release production intermediates
• Drive continuous QA improvement and ensure documentation processes (SOPs/Protocols/Reports) are followed
• Plan and conduct compliance tours and spot-check GMP areas, providing QA support including inspections
• Collaborate with departments to identify and resolve compliance/quality issues (Investigation/Deviations/Out-of-specs) affecting development
• Support Change Control and perform QA evaluation

Skills

GMP experience

Quality systems

Regulatory compliance

Communication

Independent working

On-site presence

On-call duties

Education

Bachelor’s/Master’s in a relevant science

Tools

CAPA

Deviation management

Job description

To strengthen our External and Clinical Manufacturing Quality we are looking for a talented profile to fill the position of: Internal Operations Quality Partner – Braine l’Alleud, Belgium.

About The Role

This position will support the manufacturing operational activities for UCB’s biological development projects.

You will work with

Internal Operations Quality Partner will closely collaborate and partner with various UCB teams, with a particular focus on working hand-in-hand with the Internal Bio Clin Manufacturing Team.

What You Will Do

• Work closely with Internal Bio Clin Manufacturing Team to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
• Ensure quality review of master and executed batch records for drug substance supporting clinical trial studies
• Ensure specification review and release of materials used in the production of DS (Drug substance) for Clinical Trials
• Perform release of production intermediates
• Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review).
• Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
• Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect UCB development activities and products.
• Support Change Control and perform the QA evaluation

Interested? For this position you’ll need the following education, experience and skills

• Bachelor’s, master’s degree or an education in a relevant scientific discipline
• Minimum of 5 years’ experience in GMP Environment.
• Fluent English communication (oral and written); any additional languages are a plus
• Solid understanding of the pharmaceutical biologics sector, including relevant technical elements of the business
• Experience with quality systems as deviations, CAPA, Change Controls.
• A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
• Exhibit effective communication skills when interacting with stakeholders
• Capable of working independently and taking initiative
• Must be able to act in most circumstances without direct supervision and handle complex/urgent situations.
• On-site presence required (60%)
• Perform on-call duties during weekends and public holidays on a rotating basis.
• Experience with laboratory compliance and supplier qualification process is an asset

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.