UCB Braine-l’Alleud, Walloon Region, Belgium
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UCB Braine-l’Alleud, Walloon Region, Belgium
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Make your mark for patients
To strengthen our
CMC Quality Lead – Braine l’Alleud, Belgium
About The Role
This position provides leadership and QA expertise in driving strategic Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development, including submissions, launches, product improvements and phase out.
Make your mark for patients
To strengthen our CMC Quality Leads department we are looking for a talented profile to fill the position of: CMC Quality Lead – Braine l’Alleud, Belgium
About The Role
This position provides leadership and QA expertise in driving strategic Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development, including submissions, launches, product improvements and phase out.
You will work with
This is achieved through close partnering with other functions in Quality Organization at UCB such as External & Clinical Supply Quality, Distribution and Market Quality, Devices & Primary Pack Quality, Quality Internal Manufacturing Operations and in collaboration with Patient Supply, Global Regulatory Affairs, Safety and other UCB internal teams.
What You Will Do
* Global Quality representative core member at the Technical Satellite Team (TST). TST Core Members are representatives of their respective Functional Areas within TST. They have a comprehensive understanding of the overall program and actively engage with relevant functional and cross-functional stakeholders to achieve the following accountabilities:
o Defining and implementing solutions & plans to achieve the overall product strategy, making recommendations to the TST, and driving the implementation of selected scenarios within agreed timelines
o Providing consolidated insights by collaborating with relevant functional and crossfunctional stakeholders through a structured sub-team that forms the extended TST, ensuring solutions and plans are feasible from technical, resource, and budget perspectives (according to their functional governance).
o Reporting risks and issues promptly and supporting resolution strategies.
* Owner of the Quality resources and capacity overview for project associated with the Product
* Support preparation and execution of product launches from QA perspective (e.g. launch strategy, align QA activities, submission review, attend launch team meetings, etc. ... )
* Ensuring review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned product
* Be point of contact in Global Quality for regulatory inspections related to the assigned product, ensuring preparation in accordance with inspection readiness internal guidance and availability of key stakeholders for support during the inspections. Support post inspection observation closure
* Review and approve Product Stability Strategy and Annual Stability Plan for accountable products
* Own and maintain detailed QA Product Flow Overview globally for assigned products
* Represent the CMC Quality Lead team or CMC Quality when assigned to projects and initiatives where the CMC QL presence or product expertise is required
* Critical product quality defects which may lead to product recall: - Be central point of QA contact for the organization for accountable products
* Oversee Annual Product Quality Reviews for accountable products. Review and approve Executive PQR Summary Reports for accountable products
Interested? For this position you’ll need the following education, experience and skills
* Bachelor’s, master’s degree or an education in a relevant scientific discipline
* 6-8 years of experience in the pharmaceutical/biotechnology sector, particularly in GMP area
* Advanced level and competence in speaking, comprehension, and writing in English language which is the main day-to-day language required for this position
* Experienced 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
* Ability to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
* Ability to interact with and influence senior internal and external personnel on many aspects of project and product related matters.
* Excellent managerial skills in projects/ activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results
* Capable to independently analyze data and information to draw conclusions and make effective decisions
* Ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way
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.
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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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