DSP Bio DS Operations Quality Specialist

About the role

The DSP Bio DS Operations Quality Specialist will ensure quality oversight of downstream manufacturing activities at UCB’s new commercial biological drug substance facility in Braine‑l’Alleud. The role guarantees compliance with regulatory and internal standards, maintains a continuous presence on the shop floor, and drives solution‑oriented quality improvements.

Key responsibilities

• Ensure high‑level production comprehension and implement quality enhancements on the shop floor.
• Participate in the facility Quality Operational Team meetings, sharing production knowledge and highlighting quality challenges.
• Summarize and share deviations, CAPA, and change controls with the quality team.
• Train and coach GMP Facilitators to achieve strong process and quality knowledge.
• Review and approve GMP documentation such as SOPs, master batch records and protocols.
• Support batch record review and release, providing quality oversight during manufacturing.
• Assist in audit and inspection readiness, hosting regulatory inspections and contributing to continuous improvement initiatives.

Required profile

• Master’s degree in Life Sciences, Engineering, Pharmacy or a related scientific field.
• Minimum of 5 years’ experience in the pharmaceutical industry.
• Fluent English and French communication (oral and written).
• Knowledge of downstream processing and cGMP environments.
• Experience with quality systems (deviations, CAPA, change control, risk management).
• Ability to drive continuous improvement and data‑based decision making.
• Proven capacity to thrive in demanding, high‑pressure environments.
• On‑site presence required.

Required skills

• Downstream processing
• cGMP environments
• Quality systems (deviations, CAPA, change control, risk management)