Make your mark for patients

To strengthen our Quality department, we are looking for a talented professional to fill the position of: Evidence Quality Lead – Braine l’Alleud, Belgium

 

About the role

As part of the UCB Quality organization, the Early & Clinical Development Quality Lead (ECDQL) actively promotes quality and GLP GCP GVP compliance during the early development, clinical development and post-marketing phases of UCB compounds at a global level. Collaborating with internal teams and external stakeholders, the ECDQL plays a crucial role in ensuring quality by design and maintaining continuous inspection readiness.

 

You will work with

You will work closely with a variety of internal functions within Quality and the Business area’s you support,  Additionally, you will engage with external partners and vendors to ensure compliance.

 

What you will do

Develop and Maintain the Quality Strategy at a Compound Level

Create and sustain a quality roadmap for strategic quality objectives, covering the clinical development and post-marketing phases,Identify and manage risks using a risk-based approach across compounds, processes, systems, sites, and vendorsEnsure compliance with GxP regulations, guidance, and internal procedures while reducing complexity

Proactively Identify Opportunities to De-Risk at a Compound Level

Plan and execute quality activities independently to ensure subject safety and data integrity, complying with protocols and regulationsLead compliance investigations and ensure timely closure of corrective and preventative actions from deviations, audits and inspectionsEscalate issues early and ensure effective resolution or measures are in placeLead or contribute to complex projectsManage pre-inspection documentation, quality reviews, in collaboration with functional SMEs and global process owners.

Monitor Performance

Conduct analytics and qualitative assessments to identify trendsMonitor quality deliverables from vendors and partners, sharing updates with internal functionsEnsure continuous inspection readiness and integrity of the data included in regulatory dossiersead/support inspections and investigations, coordinating responses and hosting strategies

 GCP/GLP/GxP Quality Advisor Responsibilities

Review and implement updates to GxP legislation, define best practices and assess the impact on procedures, systems and contractual arrangements

Provide expert advice to mitigate compliance risks or to address complex issues.Deliver presentations to peers, senior management, and industry audiences

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

Bachelor's degree in a relevant scientific or healthcare-related fieldMinimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research, clinical development or Pharmacovigilance.Proficient in research/GLP, GCP and/or GVP regulationsAbility to translate regulatory and quality expectations into operations, based on knowledge of quality principlesExperience in GLP, GCP and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an assetAbility 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 approachManages quality and compliance issues with diligence, rigor, transparency and timelinessStrong 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 skillsProficient in MS Office Suite; experience with statistical programs, SAP and Veeva is an advantage

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.