Vendor Quality Lead DP & QP

Contenuto del lavoro

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, Vendor Quality Lead Drug Product /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 environmentwhere you will:

• Support the Qualified Person (QP) in relation to all batch release activity for Global products produced by third parties, primarily performing QA review of batch documents, issue of batch certificates, and transactional release activities.
• Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (UCB Vendor Team, GQL, ILA, ALO, Business) to allow assessment.
• Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, QuickScore) and track the vendor’s performance
• Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
• Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
• Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
• Be the point of contact for post-release vendor issues (supply chain, distribution, etc.)
• Perform pharmaceutical drug product/finished good release at UCB Pharma SA Belgium as appropriate. This position will also deputize for the QP during absence or travel.
• Provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for UCB Products.
• Achieve close partnering with QA management within UCB and at interfaces with Product Global Quality Leads, Vendor Quality Leads for other vendor sites, and in collaboration with UCB Technical Operations and other UCB teams (Vendor Team, Extended Vendor Team).
• Support the QP in relation to all batch release activity, primarily performing QA review of batch documents
• Issue batch certificates for product release and distribution
• Perform in SAP the transactional product release and maintenance of batch release register

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

• Minimum of 5 years working in the pharmaceutical / biologics industry in a quality management position. Operational GMP experience would be a distinct advantage.
• Experience in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness.
• GMP auditing experience is an advantage
• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
• Must be able to act in most circumstances without direct supervision and handle

Why you should applyWe can offer you 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.