Biologics Quality Partner — Internal Operations

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

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.