Development Quality Operations Data Integrity Partner

Development Quality Operations Data Integrity Partner focuses on compliance support: ensuring adherence to gmp/gdp regulations, health and safety guidelines.

What the role involves

• Compliance Support: Ensuring adherence to GMP/GDP regulations, health and safety guidelines.
• Lead meetings to manage Data Integrity (DI).
• Data Integrity Management: Active participation in QA forums.
• Documentation Systems: Supporting and maintaining compliant documentation processes for UCB development activities.
• Issued Copy Process: Acting as Reconciler to verify correct completion of the “issued copy” process and coordinating local instructions with stakeholders to maintain common practic.

Confirmed role details

• Providing GMP/GDP expertise and data integrity training to customer department members.
• QA Dev Compliance Oversight: Ensuring QMS compliance with regulations and policies, coordinating daily QA systems and DI activities.
• Audit Management: Coordinating audit preparedness, managing responses to audit observations including CAPA activities.
• Continuous Improvement: Driving improvement opportunities related to QMS, Data Integrity, and Documentation Control.

Additional role context

• We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.
• 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.