Publiée le 18 juin
Mission du poste
Make your mark for patients
To strengthen our External Supply Quality department, we are looking for a talented profile to fill the position of: Vendor Quality Lead & QP – Braine l’Alleud, Belgium.
About the role
As a member of the External Supply Quality team, the Vendor Quality Lead (VQL) will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for UCB Products.
You will work with
The Vendor Quality Lead (VQL) works closely with QA management within UCB and interfaces with other internal functions like Product CMC 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).
What you will 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 and investigations, retrieve and collect supportive information from involved stakeholders (UCB Vendor Team, CMC Quality Leads, 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 and track the vendor’s performance;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 vendors;Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the established lead times. Ensure that this review is documented and made available in the UCB EDMS;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;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;Ensure review of relevant RA dossier section related to the assigned vendors;Support on customer audits and Health Authority inspections at the vendors, as neededDrive resolution for complex quality issues related to the vendors in scope.Support the QP in relation to all batch release activity, primarily performing QA review of batch documents. Issue batch certificates for product release and distributionPerform in SAP the transactional product release and maintenance of batch release registerDeputize for Qualified Person To perform the Qualified Person (QP) function regarding Batch Release as defined by Directive 2001/83/EC and related legislationInterested? For this position you’ll need the following education, experience and skills
Master’s degree or an education in a relevant scientific disciplineA minimum of eight years of experience in Quality Assurance within the pharmaceutical sector is requiredMust hold a valid Qualified Person (QP) Certification NumberFluent English communication (oral and written); any additional languages are a plusGood knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)QA/compliance experience in pharmaceutical regulated environmentGood 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” issuesDemonstrates initiative and an ability to help team and others identify and facilitate resolution of problemsAble 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 situationDemonstrated proficiency in risk analysis methodologiesAre 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!
