ESO QA Lead Japan (Group Manager)

Company Overview
◆グローバルランキング5位以内
◆ヨーロッパヘッドクオーター
◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ
◆癌領域に最先端の技術

Job Description
ESO QA Lead Japan (Group Manager)

Job Purpose
To provide leadership and manage a team of Quality Assurance Managers for ESO Quality in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements and the Quality Manual and Policies.

Major Accountabilities
・ Ensure that all aspects of the manufacturing products for the company at identified CMOs and Suppliers comply with the requirements of the Quality Manual and Policies and meet all relevant cGMP, regulatory and legislative requirements.
・ Provide leadership, direction and support to third parties (both local and global sup-pliers) and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties in a safe manner. This includes regular site visits to local suppliers.
・ Lead External Supplier’s Qualification process in conjunction with the QAM.
・ Ensure that QAMs are meeting requirements associated with NOSCEE, Quality Agreements, audit plans, supplier qualifications, Batch Record Qualification and change control.
・ Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the third parties.
・ Responsible for driving/initiating External Supplier Quality Risk assessments in conjunction with the QAM for all External Suppliers within the responsibility of the team. Gaps identified in Quality Systems will need to be remediated. Execution is to be monitored to ensure that issues are suitably addressed.
・ Lead site readiness for regulatory inspections at External suppliers where appropriate.
・ Lead site remediation from regulatory inspections and audits.
・ Review all Critical Quality Issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) in conjunction with the QAM according to the Quality Assurance Agreement and the Quality Manual. Ensure investigations are correctly executed. Ensure they are updated in AQWA (Adaptable Quality Workflow Application).
・ Responsible for assessing Quality trends and leading Continuous improvement for processes and product quality performance across external suppliers.
・ Escalate all potential quality issues as per the company's escalation policy and to higher level management, especially the ESO QA Head, and initiate all actions as de-fined. This includes escalation of issues due to inadequate resources to perform quality oversight and duties.
・ Act as deputy for the ESO QA head. This includes escalation of quality issues to ESO Global QA head in absence of the ESO QA Head.

Requirements
・ Education: Higher university degree (e.g. MS or Ph.D.) in Biochemistry, Chemistry, or another related science
・ Languages: Fluent in speaking / writing in English. Local language fluency preferred
・ Experience: 10-15 years working experiences in a GMP environment like QA operations, pharma production, R&D, QC and/or other related area mandatory.

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