Vendor Quality Lead

il y a 2 jours

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** **- Braine l’Alleud, Belgium**

**About the role**

This role involves leading and providing expert QA guidance for strategic and operational Quality Assurance activities related to global vendors (Contract Manufacturing Organizations) involved in GMP manufacturing for UCB products. The VQL in this role will be responsible for overseeing the activities at the designated external manufacturing sites.

**You will work with**

As a Vendor Quality Lead, the success in this position will be achieved through close collaboration with the QA organization at UCB, as well as with Product CMC Quality Leads, Vendor Quality Leads at other sites, and UCB Technical Operations, along with 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
- 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
- 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
- Participate on ad-hoc basis to the UCB Product/Global Change Control Committees for activities related to 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
- Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
- 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.
- Drive resolution for complex quality issues related to the vendors in scope. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems

**Interested? For this position you’ll need the following education, experience and skills**
- A master’s degree is required, with a Qualified Person (QP) certification being an advantage
- Extensive experience of 5 to 10 years in the pharmaceutical sector is required, with a strong preference for experience in Quality Assurance/GMP manufacturing
- Fluent English communication (oral and written); any additional languages are a plus
- Effectively interact with and influence senior internal and external people on many aspects of project and product related matters.
- Ability to manage projects across global geographies within the area of expertise.
- Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations
- 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 role model for others in driving the departmental/company vision
- Must be skilled and experienced in operating across cultures and in a multi-cultural environment
- Be a team player who thrives on collaborating with diverse individuals across various departments
- Demonstrate flexibility and adaptability, capable of adjusting to changing priorities and dynamic work environments. Open to new ideas and approaches, ensuring to effectively manage unexpected challenges
- Excel in building strong relationships with colleagues, stakeholders, and vendors. Possess excellent negotiation skills to foster long-term partnerships

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

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