We are looking for a Vendor Quality Lead
Location: Braine-l’Alleud, Belgium / Hybrid
Job Type: Full-time Department: Global Quality Assurance
For this position, knowledge in Chinese is a real asset!!!
The Role
We are looking for a Vendor Quality Lead to provide strategic leadership and in-depth QA expertise for our complex Global Vendors (Contract Manufacturing Organizations - CMOs).
In this role, you will be the driving force behind QA activities associated with GMP manufacturing for UCB Products. You will act as a key partner between UCB’s internal Quality management, Technical Operations, and our external manufacturing partners to ensure the highest standards of quality throughout the entire product lifecycle.
Key Responsibilities
* Strategic QA Point of Contact: Lead investigations, deviations, and out-of-specifications (OOS) for assigned vendors.
* Vendor Performance: Manage QA metrics (KPIs) and drive quality performance through recurrent vendor meetings and strategic reviews.
* Quality Agreements: Take full ownership of establishing and maintaining up-to-date Quality Agreements with global partners.
* Compliance & Product Oversight: Ensure Product Quality Reviews (PQR) and Annual Stability Programs are executed flawlessly and documented in our EDMS.
* Issue Resolution: Lead Root Cause Analysis for complex quality issues and coordinate Corporate Technical Review (CTR) meetings when necessary.
* Risk Management: Act as the primary QA stakeholder for Vendor Risk Management and challenge current practices to drive continuous improvement.
* Life Cycle Management: Oversee the product journey from Tech Transfer and commercialization to phase-out.
* Audits & Inspections: Monitor HA inspections and UCB audits at vendor sites, tracking CAPA implementation to ensure full compliance.
Your Profile
* Education: Master’s Degree or Ph.D. in a scientific field (Pharmacy, Chemistry, Biology, etc.).
* Experience: Proven track record in the global pharmaceutical industry with deep knowledge of GMP regulations and business/technical operations.
* Expertise: Strong background in Root Cause Analysis and risk assessment/management.
* Leadership: Ability to influence senior internal and external stakeholders and manage projects across global geographies.
* Soft Skills: Excellent interpersonal and communication skills, with the professional maturity to handle complex, high-pressure situations.
* Languages: Fluent in English and knowledge in Chinese.