Evidence Quality Lead

UCB; Eigenbrakel; Sur place; EUR 80 000 - 100 000; Plein temps

Résumé du poste

UCB, located in Eigenbrakel, Belgium, is seeking an Evidence Quality Lead to ensure compliant Research and Development processes. This role involves developing quality strategies, managing risks, and ensuring GxP compliance.

The ideal candidate will have over 10 years of experience in the pharmaceutical industry, strong analytical skills, and fluency in English. Join UCB to play a pivotal role in quality management and patient access initiatives.

Qualifications

• Minimum of 10 years in the (bio)pharmaceutical industry.
• At least 5 years in research or clinical development.
• At least 2 years of experience within the ATMP regulatory framework.
• Fluent English communication (oral and written).
• Experience in GLP, GCP and/or GVP quality auditing.

Responsabilités

• Develop and maintain the Quality Strategy at a Compound Level.
• Identify and manage risks using a risk‑based approach.
• Ensure compliance with GxP regulations and internal procedures.
• Conduct analytics and qualitative assessments to identify trends.
• Lead compliance investigations and ensure timely closure of actions.

Connaissances

Quality strategy development

Risk management

GxP compliance

Data integrity

Analytical skills

Formation

Bachelor's degree in a relevant scientific or healthcare‑related field

Description du poste

About The Role

As part of the UCB Quality organization, the Evidence Quality Lead (EQL) actively enables compliant Research, Development and Pharmacovigilance processes (GLP, GCP, GVP) from candidate to asset delivery, to commercial branding, with a focus on successful global launches and sustainable access for our patients. The EQL collaborates with internal teams and external stakeholders, playing 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 areas you support, and engage with external partners and vendors to ensure the integrity of data for delegated activities.

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 vendors.
  • Ensure 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 regulations.
  • Lead compliance investigations and ensure timely closure of corrective and preventative actions from deviations, audits and inspections.
  • Escalate issues early and ensure effective resolution or measures are in place.
  • Lead or contribute to complex projects.
  • Manage pre‑inspection documentation, quality reviews, in collaboration with functional SMEs and global process owners.
• Monitor Performance
  • Conduct analytics and qualitative assessments to identify trends.
  • Monitor quality deliverables from vendors and partners, sharing updates with internal functions.
  • Ensure continuous inspection readiness and integrity of the data included in regulatory dossiers.
  • Lead or support inspections and investigations, coordinating responses and hosting strategies.
• 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 address complex issues.
  • Deliver presentations to peers, senior management and industry audiences.

Qualifications

• Bachelor's degree in a relevant scientific or healthcare‑related field.
• Minimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research or clinical development.
• At least 2 years of experience within the ATMP regulatory framework.
• Fluent English communication (oral and written); additional languages are a plus.
• Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles.
• Experience in GLP, GCP and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an asset.
• Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results.
• Skilled in influencing others within a global matrix organization and driving informed decision‑making.
• Capable of prioritizing and focusing on critical issues using a risk‑based approach.
• Manages quality and compliance issues with diligence, rigor, transparency and timeliness.
• Strong analytical skills with experience in analyzing and synthesizing complex data.
• Proficient in presenting complex projects and issues clearly and succinctly.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.