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Early & Clinical Development Quality Lead, Braine-l'Alleud
Client:
UCB
Location:
Braine-l'Alleud, Belgium
Job Category:
Other
EU work permit required:
Yes
Job Reference:
1ec6eca6f1f6
Job Views:
3
Posted:
15.02.2025
Expiry Date:
01.04.2025
Job Description:
Make your mark for patients
To strengthen our Quality department, we are looking for a talented professional to fill the position of: Early & Clinical Development Quality Lead.
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 areas 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 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.
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 field.
* Minimum 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 regulations.
* 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.
* Expertise in managing transversal quality optimization projects and resolving complex issues.
* Excellent planning, organizational, presentation, training, communication, and interpersonal skills.
* Proficient in MS Office Suite; experience with statistical programs, SAP, and Veeva is an advantage.
If you are interested to learn more about R&D within UCB, please find more information here.
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!
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