Make your mark for patients

To strengthen our Internal Manufacturing Quality department we are looking for a talented profile to fill the position of: Head of QA for QC Operations – Braine l’Alleud, Belgium

 

About the role

As a member of the Internal Manufacturing Quality Assurance (IMQ) Leadership team, the global position of Head of QA for QC Operations is responsible for overseeing and ensuring the quality and compliance of Patient Supply Quality Control (PSQC) processes and operations from late development to commercialization phase of global UCB products.

You will be leading a team that is  responsible for the oversight and management of global analytical processes and governances, global Digital Technology lab systems for UCB sites, Manufacturing site QC Operations, contract laboratories oversight, corporate analytical operations such as stability program & global operations, lab critical materials operations, UCB method lifecycle, pharmacopeial compliance and raw materials vendor certification. 

 

You will work with

All the Global Quality teams and pillars in UCB, especially with the IMQ teams and the PSQC teams

 

What you will do

Global analytical processes and governances including but not limited to global method & specification management, stability, invalid management, Environmental Monitoring, etcGlobal Digital Technology (DT) QC laboratory systems including implementation and maintenance of LIMS, Empower and other global laboratory tools.Corporate analytical operations including but not limited to stability program and operations, Laboratory Critical Materials management, centralized PSQC activities (quality oversight of Contract Laboratory Organizations, vendor certification, pharmacopeial changes, UCB analytical method lifecycle incl. Invalid assay, etc.)Promote continuous improvement and alignment of practices between UCB QC sites and within QA organization.  Develop and implement strategies that will assure the establishment and maintenance of a State of Compliance and a State of Control for Quality Control Operations.Pro-actively identify, develop and implement technically robust and compliant corporate systems & process applicable to and in partnership with PSQC, in response to business requirements, technical changes and regulatory requirements.Ensure that all Systems & Processes developed and implemented by QC organization comply with applicable local & international regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and relevant UCB Corporate Policies & Procedures.Collaborate with QA teams (CMC Quality, External & Clinical Supply Quality, Internal Manufacturing Quality, etc.), Patient Supply teams and associated business stakeholders in an effective and efficient way. Implementation of relevant Quality & Compliance indicators, ensure timely follow-up on routine quality activities, active contribution to continuous improvement opportunities and communicate results to appropriate levels of the organizationWork in accordance with UCB HS&E and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development

 

Interested? For this position you’ll need the following education, experience and skills

Bachelor’s, master’s degree or an education in a relevant scientific disciplineMinimum of 15 years in a regulated pharmaceutical environment or other life science or health related field, including a minimum of 10 years in Quality Assurance / Quality ControlFluent English communication (oral and written); any additional languages are a plusDemonstrate suitable leadership to manage a team of QA professionalsMust be experienced and knowledgeable with QC Lab operations, quality management systems and related regulatory requirementsKnowledgeable of trends relative to the analytical area (operational excellence, digitalisation or regulatory compliance) Ability to lead, motivate & inspire project teams across geographies within the area of expertiseExperienced with investigation and risk management processes Ability to balance multiple priorities, provide leadership and prioritisationFact based decision maker with accountability and delivering attitudeExcellent team player attitude with excellent interpersonal relationship skillsExcellent oral and written communication skills, along with strong organization and coordination abilitiesIndependently identify problem situations, communicate appropriately and initiate problem solving processAbility to effectively interact with and influence senior internal and external personnel on many aspects of project related mattersCapable of independently analysing data to draw conclusions & resolve conflict situations

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 around 8,500 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 equitable 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. 

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
 
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.