Evidence Quality Lead

UCB - Union Chimique Belge

Bulle, Switzerland

About the role

As part of the UCB Quality organization, the Evidence Quality Lead (EQL) actively enables compliant Research, Development and Pharmacovigilance processes (i.e., GLP GCP GVP) from candidate to asset delivery, to commercial branding, with a focus on successful global launches and sustainable access for our patients. Collaborating with internal teams and external stakeholders, the EQL 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 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/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 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 field;
Minimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research or clinical development;
Fluent English communication (oral and written); any 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.