Lead, Quality Assurance, Vendor Management

Description 【募集の背景 / Purpose & Scope】 Responsible for management and oversight of the Quality Assurance (QA) vendor oversight program for vendors used by Astellas for GxP regulated activities, to ensure compliance with regulations in Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), and Electronic Records Electronic Signatures (ERES) and Electronic Systems / Computerized System Validation (CSV). Defines and implements the QA vendor audit strategy and executes the QA Vendor Management strategy to ensure vendor quality oversight which includes assessing vendors using risk ranking methodologies and quality evaluations. The role is responsible for developing, executing, and maintaining the Vendor Management strategy to achieve annual objectives. 【職務の内容 / Essential Job Responsibilities】 （雇入れ直後）

• Contributes to the design and strategic direction of QA Vendor Management oversight and support to the Astellas organization in collaboration with QA Leadership team and stakeholders globally.
• Responsible for the development, implementation and execution of the QA vendor audit strategy and procedures in close collaboration with all QA functions.
• Leads the creation of the vendor audit schedule based on assignment of tier to the service and risk rating of the vendor, in compliance with the pre-defined QA Vendor Management policies and procedures.
• Responsible for oversight of the execution of the vendor audits in collaboration with QA and appropriate Astellas business functions globally. Develops, maintains, and communicates vendor list including qualification status, which is the primary means of communicating the vendor status to the organization and regulatory Health Authorities for vendor selection and inspection purposes.
• Responsible for oversight of annual Audit Schedule completion for vendor audits, for evaluating new vendors or vendor services being used by the business during the fiscal year.
• Responsible for vendor oversight and risk mitigation, through participation in vendor governance activities including evaluation of quality metrics (Key Quality Indicators) and issue escalation along with appropriate Astellas business stakeholders for defined preferred providers in collaboration with the Director, QA VM.
• Leads Quality to Quality meetings with key vendors to ensure evaluation and resolution of escalated Quality issues.
• Leads Quality Issue escalation within Astellas and Vendors. Communicates and engages Astellas and Vendor Senior Leadership to drive resolution of these complex issues.
• Responsible for risk rating of vendors and tier assignment of services to determine the type of assessment required and communicates impact to stakeholders across QA Functions, Procurement and appropriate Astellas business functions.
• Serves in a leadership role in managing contract auditing companies (CAC) contracted by QA to conduct audits and trainings on their behalf, or to provide quality consultancy services. In collaboration with QA-LT members, communicates the outsourcing forecasts to the CAC and manages the contracts with the CAC. Seeks opportunities for cost-effectiveness. Drives contract negotiations in collaboration with Procurement.
• Maintains a state of Inspection Readiness : ensures that vendor auditing complies with defined audit strategies, is supported by quality documentation, and supports the Quality Systems group in ensuring that external staff training status is up to date, documented and readily available.
• Responsible for supporting the conduct of high profile / niche vendor audits including for-cause vendor audits.
• Represents QA in GxP regulated Astellas vendor sourcing initiatives globally. Provides quality requirements and evaluates potential vendors against these quality requirements. Engages QA Functions, as appropriate, to provide input on sourcing strategy objectives and communicates executed sourcing strategy outcomes across QA Functions.
• Represents QA in vendor governance and oversight activities.
• Responsible for forging strong collaborative relationships with internal QA key stakeholders and functions, and with relevant external stakeholders within the Astellas organization.
• Actively maintains knowledge on current developments in vendor management within the pharmaceutical industry and trains QA staff in vendor auditing.
• Domestic and international travel at 5-10% is required.

Specific Physical or Environmental Requirements】