Transversal Qc Lead
il y a 2 semaines
**Make your mark for patients.**
We’re here because we want to build the future and transform patients’ lives for the better.
At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.
An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?
To strengthen our Site Quality Operations department in Braine-l’Alleud, Belgium, we are looking for a talented individual to fill the position of: Head of global Quality Control
At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.
As Head of global Quality Control, you will:
- Align and improve the UCB global analytical Processes on all UCB manufacturing sites ensuring that the UCB products and medical devices are complying with the most current regulatory standard and that compliance risks are appropriately identified, escalated and mitigated.
- Implement and maintain relevant UCB Corporate Policies and Procedures on global analytical processes from phase III through life cycle of UCB products
- Manage and anticipate the regulatory aspect linked to Analytical Processes and Operations and to ensure being compliant to regulation requirement updates
- Drive the implementation of integrated digital solution for analytical processes and operations from development to commercial and contribute to ensure the interface between the laboratory expectations and IT.
You like to work in an environment where you can:
- Develop,improve,drive and/or implement global analytical processes from phase III through the life cycle of UCB products (NCE and NBE), in response to business requirements, observed issues, technical changes, identifed risks, audit observations and changing regulatory requirements.
- Ensure Analytical processes alignement within UCB QC Manufacturing sites and smooth transition from development to commercial
- Act as Process Owner for Global Analytical Processes when in charge
- Develop and put in place a system ensuring the permanent « inspection readiness » status and meeting authorities (AFMPS, FDA and EMEA) inspection requirements.
- Give the necessary support to sites during regulatory /customer inspections ( preparation phase, inspection and post inspection follow-up).
- Act as project manager/sponsor of, or as a key contributor in, transversal projects related to analytical operations and processes.
- Work cross-functionally across various internal departments, building relationships and generating engagement among internal stakeholders to create value for patients
- Develop & maintain an engaged network of experts fostering long term analytical excellence at UCB.
- Integrate information from multiple data sources to anticipate changes impacting the UCB analytical community or to foster UCB expert's advocacy to shape future changes in the analytical field, anticipating changes, threats and opportunities in the analytical field for UCB
- Grants deep drive Root cause analysis in related field and ensure strong right action plan are put in place.
- Support the Corporate QA and ME&HSE management to identify and mitigate compliance risks and resolve regulatory observations. Escalate crtitical compliance risks to Corporate QA and Manufacturing management and support local site complete resolution.
- Coordinate QC activities troughout the whole internal manufacturing network (Braine Tech Ops, Bulle, Saitama, Zhuhai & Brazil QC lab) to build state-of-the-art QC operations by ensuring competitive, costly and timely, release and stability testing while fostering safety and compliance and strategy
- Be the Risk Champion for the Sites Quality Operations organization and lead the Quarterly Risk Meeting ( i.e: identification, resolution, KPis in place )
- Promote Quality and Operational Excellence and perfect “Quality Culture”, “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” skills across the UCB Quality operations teams
You will contribute by:
- Participate to the definition of strategies in terms of Analytical Operations and associated processes
- Conduct ad-hoc analysis/reports to provide actionable insights for the global UCB Analytical Strategy
- Participate to establish the budget of the dep
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