Global Quality Lead GCP Auditing and Compliance

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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 Auditing and Compliance team, we are looking for a high caliber, self-motivated, Global Quality Lead GCP Auditing and Compliancebased in Braine l’Alleud, BelgiumAt 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 able to:

• Lead and/or participate in the development of the risk based GCP audit program through evaluation of elements of the UCB quality system and their effect on the overall state of compliance of the system.
• Perform GCP audits as per annual audit program (investigator sites, vendors, systems, … according to established audit strategy)
• Prepare, support and follow-up on GCP audits performed on behalf of UCB by external vendors and/or consultant auditors; as per established process, contracts and procedures. Ensure that execution of outsourced audits is conducted and completed in alignment with UCB audit processes and standards.
• Proactively manage findings, responses and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
• As required, issue KPIs and dashboards that allow proper identification, follow-up and review of trends; providing a comprehensive summary and analyses of the comparative risks and outcomes across the GCP quality system
• Contribute data and feedback to GCP-relevant internal stakeholders in UCB (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status.
• Support the preparation, hosting and follow up of Regulatory Authority inspections related to clinical activities, in collaboration with the Early and Dev Solutions Quality Management team.
• Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
• Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH-GCP, other applicable regulatory requirements and UCB global quality standards
• Participate in medium-long term projects within competence.
• Lead improvement initiatives, and where relevant, create and own the supportin UCB Policies and standards, oversee their deployment including training material

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

• 5-10 years of background, knowledge and experience of the (bio)Pharma industry and applicable technical aspects of the business.
• Minimum of 5 years’ experience performing GCP related audits.
• Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in GCP-related areas.
• Experience with any of the following in clinical trials is advantageous: Decentralized and/or Hybrid Trials, Wearables, Digital Diagnostics, and/or Digital Biomarkers.
• Experience with application of regulatory requirements associated with the qualification, validation, implementation, use and life-cycle management of digital systems, tools and applications
• Experience in leading full range of GCP audits for internal processes/units and external partners or vendors, and in managing/hosting regulatory inspections or third-party audits with depth of understanding of the theory and practice of quality management.

Why you should applyWe 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.RANDATUCBAbout 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.