品質保証責任者 - 製薬会社

勤務地 Tokyo, Japan
職種 正社員
給与 ¥15000000.00 - ¥16000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
Sub-specialization 品質管理 / 品質保証,
お問合せ Yuichi Matsuda
参照 JO-2010-448817
about Yuichi Matsuda

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

[Accountability]
As an Operational QA Manager, you will be responsible for designing and managing experiments using various instrumentation and analytical techniques in support of method development and ensuring compliance with Regulatory expectations and COMPANY internal requirements.
・batch release of commercial pharmaceutical products and medical devices to Japan market comply with COMPANY QMS and Japanese Regulation;
・proper manufacturing and quality control for the supplying manufacturing sites;
・quality defects are timely investigated and evaluated;
・product incident is timely managed;
・effective Quality Management System (QMS) is in place and in use
・Deliver the elements of the Japan Supply Chain and Commercial business plans relevant to the LOC Quality in accordance with our Customers and Regulatory commitments.
・Provide ongoing operational management, leadership and support to the in-market Japan Supply Chain Quality personnel for supply chain related activities by developing and ensuring implementation of the Quality/QMS which includes:
・Determine the responsibilities of LOC Quality Managers to ensure effective, overall Quality management and continuous improvement of supply chain activities in LOC.
・Ensure accurate resource planning and required skills mix and competencies are in place within the Japan LOC Quality team to ensure individuals and the organization recognize, that roles in LOC Quality offer good personal development opportunities and contribute significantly to business success.
・Ensure clear lines of communication and processes for product registration alignment between Manufacturing Sites and LOC regulatory as well as communication / knowledge with respect to regulatory intelligence within Japan.
・Create and identify opportunities to share information, documentation and knowledge between LOCs and driving simplification and improvements. Provide a forum for LOCs to participate and contribute to the ongoing development of the QMS.
・Develop and implement mechanisms for capturing QMS implementation knowledge and making this available to all Quality contacts in Japan.
・Working within the framework of governance and advocacy, communicate and where appropriate advocate with relevant body to ensure effective collaboration, up to date with regulations and intelligence.
・Act as a Quality contact for Supply chain and commercial teams as relevant in relation to Quality and compliance issues.
・Good communication and collaboration with Regulatory Authority - advocate and influence

[Responsibility]
・Lead and manage a team of LOC Quality Managers by providing direction, guidance, instruction on the application, compliance, on-going sustainability and performance of COMPANY QMS and Japanese Pharmaceutical Affairs Law i.e. Quality Requirements of Ministerial Ordinance No.136, or Quality requirements in the LOC.

[Requirements]
We are looking for professionals with these required skills to achieve our goals:
・First Degree in scientific or engineering discipline
・At least 10 years of experience in operational role in pharmaceutical industry, of which at least 3 years in Quality Assurance.
・At least 5 years in managerial position, of which 3 years as senior manager.
・Solid understanding of Quality Management Systems (QMS), its application and business objectives.
・Good quality risk management and problem solving skills.
・Good leadership skills. Competent people manager. Able to engage, coach and develop staff.
・Experience of working with and leading cross-site and multi-functional teams.
・Strong interpersonal and influencing skills to achieve a solution.
・Excellent oral and written communication skills. Able to work effectively in English.
・Self-starter and able to drive change
・Minimum 3 years in QA
・Managerial experience 5 years

[Preferred Knowledge, Skills and Abilities]
If you have the following characteristics, it would be a plus:
・Registered Pharmacist
・Good understanding of commercial company business processes related to the QMS
・Experience and exposure/involvement with commercial activities
・Experienced auditor

[Employment Type]
Full time

[Salary]
15M-16M Yen
※Experiences and skills will be considered

[Location]
Tokyo


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