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新着求人 品質保証  (FA-34)
募集職種 外資系製薬企業の QO, Director
勤務地 愛知
会社概要 非公開
The Site Quality Operations Leader is responsible for providing leadership in assuring that appropriate systems and processes are in place at the Manufacturing Site to meet or exceed the requirements of ** and the regulatory authorities for the quality of the products manufactured on site or by approved vendors. This position has a dual reporting relationship, both to the Site Leader and to the GSM Regional Quality Operations Lead; and is a member of the Manufacturing Site Leadership Team. Key focus areas and responsibilities for this position include: Overseeing all Quality Operations/Assurance functions and Site Quality Review Team (SQRT); Planning, implementing and achieving Site Quality Operations objectives consistent with Site Objectives and Global Quality Operations objectives; Providing leadership, development and direction to the Quality Operations/Assurance team; Interfacing with global regulatory agencies. The Site Quality Operations Leader will lead, manage and develop a diverse team of talented and engaged technical professionals with the responsibility of providing comprehensive support and guidance to all operations at the site in assuring **'s Quality Standards are met.
・Minimum of 10 years related pharmaceutical experience and 5 years quality operations experience with minimum of B.S., preferably M.S. in a Science related fields such as degree in Chemistry, Microbiology, Pharmacy or Chemical Engineering.
・Master's degree preferred; or equivalent combination of work experience and education. At least 5 years of demonstrated success leading and developing professional colleagues and developing a staffing / organizational structure in a QO or manufacturing environment. It is desirable to have a demonstrated success as a Site QO Leader and an agent of change. Related experience in at least 1 or 2 different pharmaceutical manufacturing facilities preferable.
・Demonstrated record of successful interaction with senior management, regulatory agencies (e.g. PMDA / MHLW, TGA, FDA, EMA, ANVISA) and other internal and external auditing groups is essential.
・Demonstration of all of the ** Manager Competencies, including Head (Decisive, Focused), Heart (Connected, Inspiring) and Guts (Courageous, Resilient).
・Must have a successful track record of continuous improvement and development / implementation of best practices in Quality Operations or manufacturing. Thorough knowledge and understanding of the technical regulatory and commercial aspects of pharmaceutical products is required. Experience in Aseptic operations is highly desirable. Possess excellent verbal, written and interpersonal communication skills. Exceptional understanding of GMPs and demonstrated leadership management, coaching, development and technical capabilities. Strong verbal, written, presentation and interpersonal communication skills. Proven ability to plan, implement, and achieve significant, complex goals and objectives. Demonstrated commitment to achieving objectives in a manner that is supportive of ** Values and PGS mission elements. Desirable to have exposure to lean, Six Sigma and Transformation.
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