Vendor Quality Lead

Il y a 2 mois

Brainel'Alleud, Belgique UCB Temps plein

**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 - External Supply Quality DS** **- Braine l’Alleud, Belgium**

**About the role**

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.

**You will work with**

As a Vendor Quality Lead you will be 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).

**What you will do**
- Be the central QA point of contact for the organization of 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 (Vendor QA KPI tracker, QuickScore) 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.
- 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 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
- 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.
- Manage and control quality documents related to the vendors in the UCB Controlled Documents System
- Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development

**Interested? For this position you’ll need the following education, experience and skills**
- Bachelor's or Master's degree required, auditor certification and preferred sciences certifications/registrations (e.g., medical, pharmacy, nursing, public health) are a plus.
- Fluent in English (oral and written); additional languages are a plus.
- Minimum of 6-10 years working in the pharmaceutical/biologics industry in a quality management position. Operational GMP experience would be a distinct advantage.
- Willingness to travel up to 30% within Europe during the first two years
- Experience in interaction with regulatory bodies and third party organizations with respect to QA systems and regulatory inspection preparedness.
- Proven expertise in conducting audits
- Good pharmaceutical technical understanding and expertise enabling to review and judge upon technical documents related to manufacturing and analytical testing.
- Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
- Must have the ability to manage projects/ activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
- Must possess excellent interpersonal, verbal and written communication skills at all levels internally and externally especially at senior management levels.
- Generate commitment from within teams, encourage and support new ideas and act as a

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