Development Quality Lead

仕事内容

Make your mark for patients

To strengthen our Quality Assurance team, we are looking for a high caliber, self-motivated, Development Quality Leadbased 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 can:

Lead the strategic quality management across Pharma and / or Biotech Sciences groups in their product and process development activities according to ICH guidelines.

Ensure that quality and compliance issues are managed with diligence, rigor and transparency in all CMC activities supporting product and process development, clinical supply manufacturing, analytical work, technology transfer, CMC filing, … from early phase to commercial launch of the product, to ensure product quality, compliance to regulatory requirements, within the business performance expectations.

Interested? For this position you’ll need the following education, experienceand skills:

Knowledge/Expertise/Skills

• You have a minimum of 7 years experience in pharmaceutical regulated environment.
• You are knowledgeable in QA and technical requirements of (Bio)Pharmaceutical development processes,
• You have 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.
• You have experience in partnering with Development stakeholders and coordinating different QA functions towards business objective achievement
• You have experience in conducting customer / vendor audits and participation in the management of regulatory inspections including PAI.
• You have a 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 (Bio)pharmaceutical sciences.
• You have experience with solid and liquid dosage forms, sterile parenteral and/or Biological product manufacturing quality assurance or development.
• Good interpersonal, verbal, and written communication and presentation skills. Effectively work under minimal supervision.
• You have some solid project management skills.
• You must have strong, organization and analytical skills.
• You are fluent and English, other languages are an asset
• You have a good knowledge of cGMP and product development regulatory requirements (eg US, European, Japanese)
• You ensure and drive continuous improvement of processes
• You identify risk and propose corrective actions
• You lead resolution of complex issues involving and coordinating multidisciplinary functions
• You coordinate duties and projects with middle senior management (TST members, Technical Chemical and Pharmaceutical teams) and also external parties
• You are able to give presentation to interdepartmental and multicultural audience
• Inspire confidence trough influencing skills and technical ability in a CMC development environment

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.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

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 neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for us?

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.