Vendor Quality Lead

Make your mark for patients

Vendor Quality Lead Drug Product

About the role:

We are looking for someone that can influence others and build and maintain solid relationships  with our vendors and also good common sense and a logical thinking mindset to join our Quality Assurance team in Atlanta! This position will provide leadership and in-depth QA expertise in driving strategic and operational Quality Assurance activities associated with complex Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for UCB Products.

This will be achieved through 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). This individual takes responsibility for above summarized scope of activities in relation to the assigned Manufacturing sites.

What you’ll do:

• 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. Acts as a coach for VQL’s with less experience.
• 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.
• When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the UCB Stability Program
• Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. Ensure that this review is documented and made available in the UCB Controlled Documents System.
• Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive Vendor Quality performance through these meetings
• Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the UCB Complaint System and provision of responses to the complainant are professionally coordinated and managed.
• If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting.
• Participate on ad-hoc basis to the UCB Product Change Control Committees for activities related to the vendors and provide in-depth expert QA advice, support and management for technical operational QA and general QA strategic matters associated with the vendors
• Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way.
• Cover the entire product life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
• Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors and ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record).

What you’ll need:

• Minimum of 0- 5 years working in the pharmaceutical / biologics industry in a quality management position. Operational GMP experience would be a distinct advantage.

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.