Evidence Quality Lead
UCB · Bulle
Job description
About the role
The Evidence Quality Lead (EQL) joins UCB’s Global Quality Assurance team to ensure compliant research, development and pharmacovigilance processes from candidate selection through commercial launch. Working closely with internal functions and external partners, the EQL drives quality‑by‑design and maintains continuous inspection readiness for global product launches.
Key responsibilities
- Develop and maintain a compound‑level quality strategy and roadmap covering clinical development and post‑marketing phases.
- Identify, assess and mitigate risks using a risk‑based approach across compounds, processes, systems, sites and vendors.
- Ensure compliance with GLP, GCP, GVP and broader GxP regulations while reducing procedural complexity.
- Plan and execute quality activities that protect subject safety and data integrity.
- Lead compliance investigations, manage corrective and preventive actions, and coordinate audit/inspection responses.
- Manage pre‑inspection documentation, conduct quality reviews with functional SMEs, and monitor vendor performance.
- Perform analytics and qualitative assessments to detect trends and support continuous improvement.
- Provide GxP advisory services, update procedures based on legislative changes, and deliver presentations to senior stakeholders.
Required profile
- Bachelor’s degree in a scientific or healthcare‑related field.
- Minimum 10 years of experience in the (bio)pharmaceutical industry, with at least 5 years in research or clinical development.
- Fluent English communication (oral and written); additional languages are a plus.
Required skills
- GLP, GCP, GVP, GxP compliance knowledge.
- Risk‑based quality management.
- Regulatory inspection readiness.
- Quality investigation and corrective‑action handling.
What we offer
- Opportunity to influence global product launches and patient access.
- Collaboration with multidisciplinary teams across the organization.
- Competitive compensation and benefits package.
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Published 1 week ago
Expires 1 month from now
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UCB
Bulle
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