Clinical Supply Vendor Quality Lead at UCB SA Canada

Braine-l'Alleud, Wallonia, Belgium -

Full Time

Start Date

Immediate

Expiry Date

02 Apr, 26

Salary

0.0

Posted On

02 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP, Regulatory Compliance, Project Management, Analytical Skills, Risk Analysis, Teamwork, Problem Solving, Communication, Documentation, Vendor Management, Auditing, Inspection Support, Operational Excellence, Temperature Excursion Evaluation, Quality Improvement

Industry

Pharmaceutical Manufacturing

Description

Make your mark for patients To strengthen our Clinical Supply Quality department, we are looking for a talented profile to fill the position of: Clinical Supply 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, but not limited to the QA review of IMP batch records, ensuring the prompt resolution of all batch manufacturing issues and ensuring close out of development related CAPAs. This role provides direct partner driven, pragmatic and proactive support for development manufacturing. The VQL is responsible for ensuring that appropriate quality systems are in place for the production, the release and the distribution of IMP for Clinical trials as required by the development team. In addition, the VQL is responsible for QA release support during regulatory inspections, active participation in the selection, evaluation, approval and maintenance of vendors and also and quality improvement initiatives. You will work with The Vendor Quality Lead (VQL) works closely with Clinical Supply Vendors, the UCB Qualified Person, and other internal UCB teams. The VQL also interacts with regulatory authorities during inspections and collaborates with vendors on quality issues, audits, and improvements to ensure clinical trial medicines meet all quality standards. What you will do 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). Provide support in the evaluation of Temperature excursions for IMP Preparation/reviewing Quality Assurance Agreements between Vendors and UCB 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 Support end-users in their day-to-day use of the system and encountered issues like incident creation and follow-up 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. 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 A minimum of eight years of experience in Quality Assurance within the pharmaceutical sector is required Fluent English communication (oral and written); any additional languages are a plus Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese) QA/compliance experience in pharmaceutical regulated environment Good teamwork and project management skills. Must have strong, organization and analytical skills. Fact based decision maker: understand complex issues and have the ability to contribute to informed decision making when working on “grey” issues Demonstrates initiative and an ability to help team and others identify and facilitate resolution of problems Able to make/influence quality/compliance decisions in a CMC development environment. Must be able to act in most circumstances without direct supervision and handle complex/difficult situation Demonstrated proficiency in risk analysis methodologies 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 over 9.000 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. At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. 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.

Responsibilities

The Vendor Quality Lead is responsible for the QA review of IMP batch records and ensuring the resolution of batch manufacturing issues. This role also involves supporting compliance with regulations and overseeing quality documentation.