Location Aichi
Job functions Healthcare R&D > Pharma QA
Job number JO-180828-170560

Job description

Global leading biopharmaceutical company with a rich and diverse product portfolio is currently searching for a Site Quality Operations Director for their manufacturing facility in Japan.

The Site Quality Operations Director 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 the company and the regulatory authorities for the quality of the products manufactured on site or by approved vendors.

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.

This position will:
1) Identify quality, process, and GMP problems and assure resolution.
2) Manage overall process in evaluating site compliance to the company’s quality standards 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) 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 field such as a 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.

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. Desirable to have exposure to lean, Six Sigma and Transformation.

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