Vendor Quality Lead

位置: Tokyo, Tokyo JP

ジョブ番号: 588

外部説明:

job title: VENDOR QUALITY LEADER (QA)

As a Vendor Quality Lead, you will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Japanese Global Vendors located (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for UCB Products.

This will be achieved through close working and partnering with UCB Technical Operations, Vendor teams, Global QA teams, other UCB teams and external parties.

As a Vendor Quality Lead, you will contribute by:

Being the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors.
Performing the QA review of deviation notifications and change controls, retrieving and collecting supportive information from involved stakeholders (UCB Vendor Team, GQL, CAS, Business) to allow assessment.

Other Duties:

Managing 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
Ensuring all Quality agreements are in place and take ownership of agreements for the vendors. Maintaining Quality Agreement with the vendors up to date and performing periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, being sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the UCB Stability Program
Ensuring the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensuring that this review is documented and made available in the UCB Controlled Documents System.
Participating as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Monitor and trend vendor performance including tracking of CAPA events and closure
Quality Complaints: Being the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensuring that initial receipt, logging of quality complaints into the UCB Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed, working with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinating vendor quality related investigations
Participating on ad-hoc basis to the UCB Product Change Control Committees for activities related to the vendors and review change controls as QA stakeholder.
Providing expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Working closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Covering the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Owning of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensuring all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensuring review of relevant RA dossier section related to the assigned vendors
Having the overview of UCB audit and HA inspections related to the vendors. Tracking and following-up on Audit observation and CAPA plan implementation at the vendor.
Being the QA stakeholder for Vendor Risk management .
Managing and controlling quality documents related to the vendors in the UCB Controlled Documents System
Providing support to customer audits and Health Authority inspections at the vendors, as needed
Receiving, coordinating, reviewing and authorizing product reworks and repackaging
Being the point of contact for post-release vendor quality issues (supply chain, distribution, etc.)

As required, provide Operational QA support to other vendors
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness) in other geographical locations
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:

Minimum of 5 years working experience in pharmaceutical Industry (either production, QA or QC)
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has a deep knowledge of the pharmaceutical industry from a business and technical perspective including manufacturing of sterile products.
Experienced in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness
Experience in conducting customer / vendor audits and participation in the management of regulatory inspections
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels
Must be able to communicate in English and Japanese language (reading, writing, speaking, comprehension when listening)
Skilled and experienced in operating across cultures and in a multi-cultural environment
Root cause and risk management/assessment skills

ジョブ番号: 588

コミュニティステータス: Vendor Quality Lead

Location_formattedLocationLong: Tokyo, Tokyo JP