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Global Quality Lead
il y a 2 semaines
About Our Team
We are a dynamic and innovative team at UCB S.A., dedicated to delivering high-quality products and services to our customers. As a key member of our R&D and Pharmacovigilance Quality (RDPVQ) team, you will have the opportunity to work with a diverse group of professionals who share a common goal: to make a difference in people's lives.
Your Key Responsibilities
- Leading a team of GLP, GCP, GVP Vendor Quality Leads (VQL)
- Coach, lead and empower a team of VQLs
- Create strategic quality objectives that focus on enabling UCB functional areas
- Ensure the maintenance and lead the development of processes, systems and tools that are lean and fit for purpose, in support of the responsibilities and activities of VQL
- Establish and build a network with UCB key stakeholders in relation to the GLP, GCP and GVP compliance reference system/data integrity and ensure connections with relevant VQLs are established
- Establish good reports with Vendor Quality counterparts and ensure regulator meetings are established aimed at ensuring compliance and data integrity during the execution of delegated activities
What We're Looking For
- Bachelor's, master's degree or an education in a relevant scientific discipline
- A minimum of 10 years of experience working in the (bio)pharmaceutical industry preferred, with a minimum of 5 years in the research, clinical development or Pharmacovigilance domain
- 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
- Proficient in MS Office Suite; experience with statistical programs, SAP and Veeva 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
