Make your mark for patients
According to the Associate Director’s instructions, QA S&CI team organization and in cooperation with Braine Technical Operations (BTO) and related supporting services,
- Assure that all technical operations related to the production & analysis of pharmaceutical products comply with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures
- (co-)develop and (co-)implement technically robust and compliant systems allowing to exploit, maintain, monitor and continuously improve operations
- Develop and implement strategies that will assure the establishment and maintenance of a State of Compliance and a State of Control
- Pro-actively identify, develop and implement quality improvements in response to business requirements, technical changes and regulatory requirements
- Drive continuous improvement projects that will allow risk reduction, Improved Quality KPI and product quality
The position’s main focus is:
- Quality Management System
- Pest control management
- Access management
- Audit management (internal and external audits and inspections)
- Continuous Improvement projects and activities
- Backup-up function
- The position can act as back-up for his direct colleagues according to his manager’s instructions and after appropriate training
- General QA Role
- Promote Quality and Operational Excellence and cultivate “Quality Culture”, “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the UCB teams
- Drive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements
- Assure and maintain efficient UCB supplier’s evaluation process for equipment, consumables and services. Support QA Utilities/Facilities with system SQR preparation and reporting. Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.
- Driving quality leadership and technical expertise on Quality Management System compliance strategy and interacting with other functional areas to effectively communicate Quality Management System requirements through coaching and training.
- Maintaining and continuously improving the Quality Management System and related processes
- audit management (internal and external audits & inspections).
- Leading or co-leading internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to GMP
- Pest control:
- Organizing and coordinating the GMP implementation of Pest control for the entire manufacturing site
- Management of Deviation, Investigation and CAPA related to pest control activities.
- Access management
- Support the facilities team for the access management (change control, deviations, ..) Support Inspection readiness program.
- As members of the inspection readiness team, participate to Audit & Inspection on site at UCB as SMEs, Front Officer and facilitator.
- Continuous Improvement
- Drive the identification of opportunities or improvement
- Develop, drive and/or implement quality improvement and operational excellence projects in response to business requirements, observed issues, technical changes, identified risks, audit observations and changing regulatory requirements
- Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP
- Eager to learn & grow in the position
- High potential with affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
- Capability to work with minimal supervision
- Ability to balance multiple priorities
- Fact based decision maker with accountability
- On-time delivering attitude
- Team player with good interpersonal relationship and communication skills
- Good oral and written communication skills
- Capable of independently identifying problem situations and initiating problem solving
- Ability to influence by persuasion
- Stress resistant
- Ability to make quality and compliance decisions in a business environment
- Fluent in French and English are required
- Ability to lead (small) projects teams and to motivate & inspire internal customers
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
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.
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 EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.