|部署・役職名||Site Quality Operations Leader|
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 the Quality Standards are met.
This position will:
1） Identify quality, process, and GMP problems and assure resolution.
2） Manage overall process in evaluating site compliance to the Quality Standards （PQS） and implement appropriate actions.
3） Manage the overall assurance and disposition of products produced at the manufacturing site or by approved vendors.
4） Approve quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications.
5） Review key quality and regulatory documentation and implement appropriate actions.
6） Lead and engage the site quality review team （SQRT） and AQRT process to ensure site regulatory compliance to ensure marketed product quality. Responsibility for site regulatory inspections.
7） Coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality Operations colleagues. Manage talent development to assure adequate current capabilities and future succession for critical positions.
8） Develop and maintain an organizational structure consistent with the area needs and goals, including the preparation
and administration of annual performance assessments and discussions.
9） Optimize site effectiveness and efficiency to ensure site performance goals are achieved or exceeded without compromising quality and compliance.
11） Provide strategic leadership to QO and to the site on quality.
12） Be a voice for change and continuous improvement.
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 or equivalent knowledge.
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.