Internal Gene Therapy Manufacturing Operations Quality Partner

UCB; Eigenbrakel; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

UCB in Braine l’Alleud, Belgium is looking for an Internal Gene Therapy Manufacturing Operations Quality Partner. This pivotal role involves ensuring the quality of Drug Substance operations, compliance with regulations, and continuous improvement of quality assurance processes.

The successful candidate will collaborate with Clinical Manufacturing and various stakeholders to maintain the highest standards while supporting compliance and operational efficiency.

Qualifications

• Must have extensive experience in pharmaceutical regulated environments including ATMP.
• Should understand GMP compliance principles and risk management.
• Experience with failure investigations and root cause analysis is a plus.

Responsabilités

• Oversee Drug Substance development and manufacturing activities.
• Ensure compliance and quality review of batch records.
• Drive the continuous QA improvement process.

Connaissances

Fluent English and French communication

Extensive experience in pharmaceutical regulated environments

Deep expertise in Drug Substance and single use technologies

Experience managing regulatory inspections

Strong interpersonal and communication skills

Formation

Bachelor’s/master’s degree in a relevant scientific discipline

Description du poste

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

About The Role

As a key member of the Internal Gene Therapy (GT) Operations Quality team, you will be reporting to the Head of Internal Gene Therapy Manufacturing Operations Quality. You will be responsible for overseeing Drug Substance (DS) development and manufacturing activities within the Gene Therapy Pilot Plant (T4). The position drives continuous QA improvement by ensuring that the Quality Management System and all CMC‑related development activities operate efficiently, consistently deliver high product quality, safety, efficacy and fully meet regulatory expectations.

In addition, the role ensures that all operational and quality activities remain compliant with applicable regulations while supporting strong overall business performance.

You will work with

In this role, you will collaborate closely with the Clinical Manufacturing team, as well as CMC Development, QC, Engineering and Technical Transfer groups to ensure high‑quality Drug Product operations. They will also interact regularly with manufacturing, facility operations, logistics and laboratory teams to resolve deviations, manage changes, and maintain compliance. In addition, the role works in alignment with the broader Internal Gene Therapy Operations Quality team and various stakeholders to support inspection readiness and drive continuous quality improvement.

What You Will Do

• Work closely with Internal Gene Therapy Pilot Plant Clinical Manufacturing Team in charge of the Drug Substance (DS) activities
• Ensure quality review of master and executed batch records for drug product supporting clinical trial studies and commercial launch.
• 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
• Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review /approval Tech Transfer).
• 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

Requirements

• Bachelor’s/master’s degree or an education in a relevant scientific discipline
• Fluent English and French communication (oral and written); any additional languages are a plus.
• Extensive experience in pharmaceutical regulated environments, including ATMP and Drug Product manufacturing, isolator technologies and related quality requirements
• Deep expertise in Drug Substance, single use technologies and pharmaceutical development processes quality assurance.
• Experience managing regulatory inspections (including PAI) and ensuring compliance across manufacturing, facility operations, logistics, laboratory, and quality systems.
• Skilled in compliance, quality assurance/control, validation, technical services, and at least one scientific discipline related to pharmaceutical sciences
• Understands practical applications of GMP, compliance principles and theories including risk management
• Demonstrated autonomy and effectiveness in complex situations, influencing stakeholders and driving results across departments
• Excellent interpersonal, verbal and written communication skills at all organizational levels.
• Generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental/company vision.
• Develops innovative solutions using sound judgment and extensive quality experience.
• Experienced in failure investigations and root cause analysis; coaches others to resolve problems creatively and effectively.

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.