Make your mark for patients

To strengthen our R&D Quality department we are looking for a talented profile to fill the position of: Solutions Quality Lead – Braine l’Alleud, Belgium

 

About the role

This position will consist in creating value by contributing to quality directions and insights that protect patients and ensure sustainable compliance. Participate in inspection readiness activities for real-time readiness and preserve UCB’s reputation in early pharmaceutical development. Provide quality support to research and clinical operations within the scope of GLP, GCP Lab, and HTA/HBS Compliance Programs, ensuring the implementation and maintenance of UCB quality standards and policies within Patient Solutions.

 

You will work with

 In this role, you will work closely with various stakeholders across multiple functions. You will collaborate with Global Quality Auditing, Quality Systems & Governance, , business stakeholders within Research, External Innovation and Operations and Early Clinical Development and Translational Sciences and transversal UCB communities. Your role will involve contributing to process improvements, ensuring alignment with UCB Policies and Procedures and regulatory requirements.

 

What you will do

 Process Improvement Contributor

Evaluate updates to global regulations to identify changes needed and implement through change control process of UCB Policies, SOPs and related controlled documents related to GLP and GCPContribute to and/or review procedural documents according to UCB Policies and Procedures relating to GLP activities in Policies, SOPs and related controlled documents to ensure applicable regulatory requirements

Audit Management Contributor

To support OECD principles, create a quarterly annual audit schedule/plan to record GLP and GCP Lab compliance during the conduct of GLP and GCP Lab studies, in support of UCB candidate development.When requested, conduct auditing of Study Plans and Amendments, Study Phase Reports and Research Reports according to UCB Policies and Procedures

Issue Management Contributor

Contribute to investigations of non-compliance to areas of research and development operations which are within the scope of the Good Laboratory Practice (GLP) Compliance Program, the Good Clinical Practice (Laboratory) Guidelines (GCP Lab), and relevant Human Tissue regulations according to UCB Policies and ProceduresWhen requested, facilitate discussions with internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance to according to UCB Policies and Procedures and OECD Principles.  

Vendor Management Contributor

When requested, contribute to the assessment of the capabilities of potential vendors of non-clinical and ancillary services in GLP-regulated and GCP Laboratory activities at the local or global level in collaboration with R&D and PV Q team members and according to UCB Policies and Procedures  

Inspection Readiness Management Contributor

Support and/or function as a liaison during GLP/GCP/HTA inspections and investigations conducted by international and national authorities or business partners according to UCB Policies and Procedures

GCP/GLP/GxP Quality Contributor

Utilize knowledge and understanding of applicable regulations and quality principles to collaborate effectively and ensure work products and outputs are aligned with OECD GLP regulations, ICH guidelines, Human Tissue Regulations, and any other applicable regulatory requirements or UCB global quality standards.Conduct and/or collaborate in the delivery of data analytics and qualitative assessments to deliver insights, independently from the business or other quality functions.When requested, lead and/or participate in Quality Initiatives

Other Responsibilities

When requested, represent R&D and PV Quality at interdepartmental, project and study team meetings as an individual contributorParticipate in the delivery of presentations to peers and as requested, senior managementWhen requested, provide mentoring and guidance to other members of the R&D and Pharmacovigilance Quality team.

 

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 disciplineFluent English communication (oral and written); any additional languages are a plusAbility to drive collaboration and engagement across the stakeholder network, motivating others to achieve resultsSkilled in influencing others within a global matrix organization and driving informed decision–makingCapable of prioritizing and focusing on critical issues using a risk-based approachManage quality and compliance issues with diligence, rigor, transparency and timelinessDemonstrate strong analytical skills with experience in analyzing and synthesizing complex dataProficient in presenting complex projects and issues clearly and succinctlyExpertise in managing transversal quality optimization projects and resolving complex issuesExcellent planning, organizational, presentation, training, communication and interpersonal skills

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.