Quality Partner Biotech Sciences Ops&qp

il y a 2 semaines

Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients**

To strengthen our **Quality Assurance team, **we are looking for a high caliber, self-motivated**, **Quality Partner Biotech Science Ops & QP** based in **Braine l’Alleud, Belgium**.

**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.**

**You like to work in an** **environment where you will**:

- Be responsible for supporting the manufacturing operational activities in the BioPilot Plant
- Ensure all these activities meet regulatory requirements and expectations and deliver business performance.
- Act as a QP (Qualify Person) according to current regulation for Investigational Medicinal Products (IMP) and responsible for the management of batch disposition and release activities concerning the provision of DS for UCB sponsored clinical trials.
- Drive the continuous QA improvement process ensuring that Quality Management System and activities in support of CMC Development (including the review and the release of material for development for clinical trial supplies) work in a way that ensures product quality, safety and efficacy, meet the regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
- Ensure the management of the QA Operational Team supporting the manufacturing operational activities in the BioPilot Plant
- Ensure and support the QA Development project for CMC process development and clinical supply including manufacturing, review of master and executed batch records and release from early phase to commercial launch of the product.
- Ensure adequate documentation processes and systems are available and followed for CMC development projects (SOPs / Protocols review /approval).
- Ensure specification review and release of materials used in the production of DS (Drug substance) for Clinical Trials.
- Proactively support the activities of CMC and Development QA for relevant manufacturing quality systems (deviation close out / Change management/ complaints / quality improvement).
- Ensure that all operations are appropriately compliant with applicable regulations (EMEA, FDA, MHRA, etc. where relevant). Ensure an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Pilot Plant, equipment and facilities.

**Interested? For this position you’ll need the following** **education, experience** **and skills**:

- Minimum 5 years’ experience in pharmaceutical regulated environment.
- Minimum of 5 years’ experience in team management
- Must be knowledgeable in QA and technical requirements of pharmaceutical development processes.
- A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
- Experience in participation in the management of regulatory inspections including PAI.
- QA/compliance experience in IMP manufacturing, facility operation, laboratory compliance and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to pharmaceutical sciences.
- Experience with sterile parenteral and/or biological product manufacturing quality assurance experience is essential.
- Good knowledge in SAP is an asset

**Why you should apply**

We can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees - just as we do for the patients we serve.

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

**About us**
UCB is a global biopharmaceutical company, focusing on

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