Quality Partner Center of Expertise - Braine L'alleud, België - UCB

Beschrijving

Make your mark for patients

To strengthen our Quality Assurance team, we are looking for a high caliber, self-motivated, Global Quality Products, Quality Partner, Centre of Expertise 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 can:

• Provide support across the Products portfolio and independently of the development or commercial stage of the Products, expert advice, support and management for QA matters related to Global Products with focus on the following:
  • Provide technical support, review and approval of development, technology transfer, validation protocols and reports drug substance, drug product or intermediates and starting materials as required
  • Support assignments associated with the Products, or transversal projects across multiple Products
  • Drive from a QA standpoint complex investigations linked to the Products
  • Review and approval of BLA/MAA CMC sections
  • Promotion and improvement of the Quality by Design principles, within QA and with stakeholders
  • Act as SMEs in QMS processes associated to Product development, technology transfer, process validation, shipping validation and other activities as needed.
• Continuously drive for operational excellence and optimized resource utilization. Work closely with staff in the Global Quality team and key stakeholders to ensure that all QA services for the Products in scope of this role are provided in an effective and efficient way.
• Promote Best Practices throughout the Global Quality Team and where possible business stakeholders. Create as needed simplified, efficient processes and procedures to support the team's activities.
• Provide expert guidance and support to other team members and other business stakeholders in the progression of projects, resolution of issues and the creation of new guidance
• Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.

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

Knowledge/Expertise/Skills

• You have a thorough knowledge of global regulatory requirements.
• You have a minimum of 5 years working in the pharmaceutical/biologics industry in a quality or technical management position. Operational GMP experience is a distinct advantage.
• You have expert knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques
• You have a thorough understanding of relevant business units and interfaces of functional units
• You hold a substantial practical experience of application of regulations, principles, theories in complex situations.
• You have analytical skills in order to be able to manage complex issues into more manageable individual tasks
• You are knowledgeable of current and possible future trends, policies, practices, technology and information affecting business and organization.
• You have an understanding of corporate and inter-departmental dynamics and able to apply this understanding in practical situations.
• You are skilled and experienced at managing multi-cultural or multi-functional teams.
• You are able to deliver presentations or reports at executive management level or to high level industry audience with a relaxed and proficient presentation style.
• You are able to demonstrate managerial competence in stressful situations or conflicts.
• You can translate opportunities and threats into actionable strategic response.
• You can make specific changes to improve UCB systems and work processes.
• You can review and critically analyze business and other outcomes of his/her actions.
• You are able to unconditionally support key decisions once taken.
• You can identify and assess risks and propose corrective actions in unusual situations.
• You can independently assess complex processes, systems, projects and direct resolutions.
• You are able to devises novel strategies and innovative solutions aligned with corporate thinking, and based on best practices

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.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

RANDATUCB

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.