Preclinical Quality Lead

Jobinhalt

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 Quality Assurance team, we are looking for a high caliber, self-motivated:Preclinical Quality Lead, Early Solutions Quality Operations 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 environmentwhere you will:

• Partner with Early Solutions (and related departments) in facilitating the quality mindset into the preclinical portfolio across the UCB sites (Boston, Braine and Slough). This position supports operations related to local and international development of new drugs and/or new indications.
• Provide direct compliance and investigative support to areas of research operations which are within the scope of the Good Laboratory Practice (GLP) Compliance Program, the Good Clinical Practice (Laboratory) Guidelines (GCP Lab), and the relevant Human Tissue regulations
• Provide guidance and support to Early Solutions in the implementation of basic principles of Good Research Practice (GRP).
• Assist with ensuring multi-site study obligations including the Sponsor QA roles and responsibilities are met.
• As required, evaluate compliance with the Belgian Royal Decree on Biobanks, and the Human Tissue Act for working with Human Biological Samples (HBS) and Human Tissues (HTA).
• Apply appropriate level of risk-based approach and agile methodology in all activities where it is possible without compromising regulatory compliance.
• Serve in an advisory role for key internal customers and to assist with the definition and monitoring of key performance indicators (KPIs) with partnering teams. To proactively assist internal teams with the identification, development and implementation of quality improvements
• Support the Head of ESQO, who will have the capability and capacity to serve as the primary liaison during inspections and investigations conducted by international and national regulatory authorities, including any synergies across various sites related to audit observations will be disseminated and implemented appropriately.
• Maintain proactive approach to current regulatory thinking and trends through key regulatory and industry relationships

Interested? For this position you’ll need the following education, experience andskills:

• Have the mindset that demonstrates the confidence, resourcefulness and willingness to tackle any assigned task and get it done in the face of any challenges that may arise.
• Be flexible and adaptable, have a capability of leading and motivating projects with interdepartmental teams, plus innovative problem-solving skills are essential. Excellent interpersonal and communication skills are a prerequisite.
• Be a confident presenter and communicator, be able to give presentations to interdepartmental audiences and represent company with external inspectors and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.
• Have knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy.
• Be an experienced QA professional with a robust knowledge and understanding of the UK, EU and FDA regulations (GLP), as well as the UK/EMA GCP Laboratory Guidelines.
• Be able to demonstrate the necessary attributes and behaviours for working with research scientists when discussing quality matters, to the extent that they are able to develop a trusting working relationship with you.

Why you should apply?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.About Us.UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.Curious to know more? Please visit our website www.ucb.com .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/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.