Job title:
Global Quality Lead
Company:
UCB
Job description
Make your mark for patientsWe are looking for a Global Quality Lead who is motivated, collaborative, and experienced to join our Quality Assurance team, based at our UCB campus located in Brussels, Belgium. For Internal (UCB Applicant) location is not relevant.About the RoleYou will provide leadership and QA expertise to manage the lifecycle of products available on the market including submissions, launches, product improvements, and phase-outs.Who You Will Work WithYou will closely collaborate with various functions within UCB’s Quality Organization, such as GMP/GSP Quality Operations, Global Distribution, In-Market Quality, Devices and Wearable Tech Quality, as well as other internal UCB teams.What You Will Do
- You will represent Global Quality within the Technical Satellite Team.
- You will be responsible for the quality resources and capacity for projects associated with the product.
- You will support the preparation and execution of product launches from a QA perspective.
- You will review and approve CMC sections related to regulatory submissions, renewals, or variations.
- You will be the Global Quality contact for regulatory inspections related to the product.
- You will review and approve the Product Stability Strategy and Annual Stability Plan.
- You will manage the Product Change Control Committee.
- You will represent the Product at Technical Meetings with Senior Management and at Recall Committee
- You will define and establish key performance indicators for QA activities and services associated with the product.
Interested? For this role, we are looking for the following education, experience, and skills
- Degree in science, engineering, or a related field.
- Minimum of 5-8 years of experience in the pharmaceutical/biologics industry in quality management.
- Good knowledge of GMP regulations and CMC regulatory requirements.
- Experience interacting with regulatory bodies regarding QA systems and inspections.
- GMP auditing/inspection expertise.
- Excellent communication and problem-solving skills.
- Ability to work effectively in a matrix and multicultural organization.
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 with 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.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Expected salary
Location
Braine-l’Alleud, Brabant Wallon
Job date
Fri, 09 Aug 2024 02:44:09 GMT
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