Make your mark for patients
To strengthen our Clinical Supply Quality department, we are looking for a talented profile to fill the position of:Vendor Quality Lead – Braine l’Alleud, Belgium
About the role
As a member of the Clinical Supply Quality team, the Vendor Quality Lead (VQL) is responsible for reviewing IMP batch records, resolving batch manufacturing issues promptly, and closing development-related CAPAs. This role provides direct, partner-driven, pragmatic, and proactive support for development manufacturing.
The VQL ensures that quality systems are in place for the production, release, and distribution of IMP for clinical trials as required by the development team. Additionally, the VQL supports QA release during regulatory inspections, participates actively in the selection, evaluation, approval, and maintenance of vendors, and engages in quality improvement initiatives.
You will work with
This position will support operational clinical supply quality activities through close partnering with Clinical Supply Vendors. The role will involve continuous interaction with external vendors as well as internal stakeholders such as Supply Chain, Global QA, and other UCB internal departments.
What you will do
Operational
* Provide timely and efficient GMP/GDP IMP Release function to all relevant UCB project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…).
* Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc.
* Support the systems and processes in place for the appropriate documentation of UCB development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
* Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
* Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
* Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
* Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
* Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up to date, by editing and reviewing quality agreements
* Lead internal audits / Self-Inspections
* Activation of Master Data codes within SAP and ensure the role of CS Quality SAP LKU:
Process
* Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant).
* Support the Head of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities.
* Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions.
* Ensure Clinical supply Quality processes directly support Technical Operations and development partner goals and objectives.
* Review and QA approval of deviations, change controls and complaints.
Interested? For this position you’ll need the following education, experience and skills
* Minimum of 5-10 years of experience in a pharmaceutical regulated environment, especially in vendor or supplier management
* Knowledge of GDP/GCP is highly desirable
* Demonstrates exceptional proficiency in both written and verbal communication
* Fluent in English, with the ability to communicate effectively through both written and verbal means
* Strong teamwork and project management skills, with excellent organizational and analytical abilities
* Fact-based decision-maker: capable of understanding complex issues and contributing to informed decision-making in ambiguous situations
* Proactive in identifying and resolving problems, while aiding others in the process
* Able to influence and make quality/compliance decisions in a CMC development setting
* Must be capable of working independently and handling complex situations, with actions impacting multiple departments
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 equal 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 is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
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.
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