Job Description

募集要項

【求人No NJB2345040】
As the independent second line assurance function for R D our mission in Quality Assurance is to achieve enduring excellence in auditing quality management quality risk assessment and enhance the R D quality mindset for the benefit of our patients.
The Associate Director Quality Assurance is responsible for:
・ Planning leading conducting and reporting audit activities for R D GxP risk based audit programs （GCP GVP GRP Lab GCP GLP）
・ Delivery of proactive GxP inspection support and management
・ Management of significant CAPAs related to audit and/or inspection findings in collaboration with functions owning the issues.
・ Managing business relationships with defined stakeholder groups for the quality management activities （quality risk issues process etc.）.

■Audit
・ Plans leads conducts and reports audits in assigned GxP areas and types e.g. investigator site audit system or process audits and vendor audits.
・ Participate in and may lead directed （For Cause） audits.
・ Works with contract personnel or consultants to prepare conduct and report outsourced audits
・ Leads Supplier qualification activities （SQA） as assigned
・ Identify and assess gaps during supplier qualification assessments
・ Supports Due Diligence activities as assigned

■CAPA
・ Assesses need for and assists in development of CAPA plans approves and monitors plans to completion
Inspection
・ Provides QA oversight and/or management of regulatory GxP inspections
・ Collaborates with Quality Assurance lead to manage and prepare for regulatory inspections as assigned including providing training to the organisation as needed.

■General Accountabilities
・ Ensures own tasks are performed to current practices and in accordance with company policies standards SOPs and guidelines
・ Promotes a culture of ethics integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
・ Communicates effectively with QA colleagues and business stakeholders
・ Maintains knowledge of relevant industry information affecting quality and compliance arena
・ Leads training for colleagues and business stakeholders as required.
・ Involved in and may lead the development and/or revision of QA processes projects and tools
・ Mentors QA colleagues
・ Provides general support related to regulatory authority inspections as and when required
・ Provides responsive and proactive quality and compliance advice to defined customers effectively influence assigned area by being relevant GxP/quality system expert
・ Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
・ Travel expected

応募必要条件

職務経験	無し
キャリアレベル	中途経験者レベル
英語レベル	ビジネス会話レベル
日本語レベル	ネイティブ
最終学歴	大学卒： 学士号
現在のビザ	日本での就労許可が必要です

スキル・資格

■Essential
・ Degree level education or equivalent experience in clinical development or quality management
・ Experience in pharmaceuticals or a related industry
・ Excellent analytical written and oral communications skills
・ Fluent in written and spoken English
・ High ethical standards trustworthy operating with absolute discretion
・ Strong collaborative influencing and interpersonal
・ skills ・ curious to understand business environment
・ Skilled at managing using technology
・ Ability to maintain and create professional networks with stakeholders
・ Supplier qualification

■Desirable
・ Project management experience
・ Experience in managing regulatory health authority GxP Inspections
・ Key Account management
・ Audit expertise

勤務地

• 東京都 23区

労働条件

雇用形態

正社員

給与

1100万円 ~ 1600万円

勤務時間

09:00 ～ 17:15

休日・休暇

【有給休暇】有給休暇は入社時から付与されます 【有給休暇】 初年度 4～16 日 （ 1 か月目～ ） 入社月により付与日数が…

業種

医薬品

職種

会社概要

会社の種類

外資系企業

Job Tags

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