vendor quality lead.

Here are the mission as a Vendor Quality Lead :

• Ensure all Quality agreements are in place and take ownership of agreements for the vendor(s). Maintain Quality Agreement with the vendor(s) up to date and perform periodic reviews and update of the agreement in close collaboration with the appropriate stakeholders (mainly the Vendor Team and External Vendor Team) and the vendor(s).
• Ensure all relevant documentation are provided to the vendors and implemented (methods, specifications, process descriptions etc... as per QAA requirements).
• Be the central QA point of contact for the Quality management of:
• Investigations / deviations / out-of-specifications associated with the assigned vendor(s),
• Change Controls associated with the assigned vendor(s),
• Perform the QA review of the above records, retrieve and collect supportive information from involved stakeholders (UCB Vendor Team, UCB external Vendor Team, QA / Operational teams when needed) to allow assessment.
• Perform the QA approval of the above records. Ensure that reviews are documented and made available in the Controlled Documents System.
• Drive resolution for complex quality issues related to the vendor(s) in scope including coaching other VQL’s on problem solving for complex issues. 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.
• When needed work with the Vendor team and the CMC Quality Lead(s) to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting.
• Coordinate vendor(s) quality related investigations.
• Participate on ad-hoc basis to the UCB Product or Global Change Control Committees fo activities related to the vendor(s).
• Ensure the key performance indicators (metrics) for key operational QA activities and services associated with the vendor(s) are managed with the support of the Vendor
• Quality support Team. Ensure the vendor performances are tracked in the defined tracking tools (Vendor QA KPI). Manage the periodic updates of the Vendor Quality Risk Score (QRS).

Here are the rerquirements as a Vendor Quality Lead :

• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business, supply and technical perspective.
• 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 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 role model for others in driving the projects and the company vision.