QA Vendor Lead
Date: May 30, 2018
Location: Braine L'alleud, BE
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To strengthen our Commercial Quality Assurance Neurology & Established Brands team, based in Braine l'Alleud, close to Brussels, Belgium, we are looking to fill the position of:
QA Vendor Lead
Job Nature and Scope
This position 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.
The incumbent takes responsibility for above summarized scope of activities in relation to one or more Vendors located in the EU region. This will mainly comprise Quality accountability for externalized manufacture of pharmaceutical products (API, bulk, finished product).
* 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, CAS, 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 product GQLs and the vendors.
* Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the UCB Controlled Documents System.
* 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 expert QA advice, support and management for technical operational QA and general QA 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
* Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
* Ensure review of relevant RA dossier section related to the assigned vendors
* Have the overview of UCB audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
* Be the QA stakeholder for Vendor Risk management.
* Provide support to customer audits and Health Authority inspections at the vendors, as needed
Experience and skills:
Master's degree preferred (Industrial pharmacist, (Bio)Chemist, Bioengineer), and eligibility as a Qualified Person in EU would be an advantage
* At least 5-7 years of experience working in the pharmaceutical/biopharma industry in an operational quality position and with additional operational experience from other roles in pharmaceutical GMP manufacturing.
* Experience in interaction with regulatory bodies and third party organizations with respect to QA systems and regulatory inspection preparedness.
* Must be skilled and experienced in operating across cultures and in a multi-cultural environment
* Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
* Possess good auditing capabilities and skills.
* Must have the ability to manage projects/ activities across global geographies within the area of expertise.
* Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
* Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
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