Associate Director Regional Lead, Commissioning & Qualification
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
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Associate Director Regional Lead, Commissioning & QualificationApply Now
Please note that this job requires native level English(definitely)/Japanese(hopefully) language command not only in speaking, but also in business writing and reading. (English language : TOEIC参考730点以上)
Global Engineering is maintaining Takeda long-range capital investment strategy and portfolio and leads as the center of expertise for engineering across the production network. We make sure the company introduces best practices and up-to date technologies and implements global strategies on engineering, maintenance, project management, automation and qualification. Reginal Engineering Japan has responsibility for Japan site. (Osaka, Hikari, Fukuchiyama, NIhon seiyaku Narita, Nihon seiyaku Osaka)
- As member of the regional Engineering Team, the Regional Lead, Commissioning & Qualification provides guidance and support to all site Project Management and Engineering Services Teams on Commissioning, Qualification and Validation activities within the region. The Regional Lead reports to the Regional Head of engineering and will support both the site leadership teams as well as the Global Engineering Team to drive business performance consistent with the TAKEDA´s core values of Patient – Trust – Reputation – Business.
- The Regional Lead is responsible for the implementation of good Commissioning and Qualification (C&Q) plans and practices and support the sites on subsequent planning and execution of validation activities.
- The Regional Lead will work closely with the Site Engineering Services Lead and teams and will liaise with external qualification service providers to ensure proper C&Q staffing options for capital investment projects and routine operations.
DIMENSIONS AND ASPECTS
- Drive Best highest safely standards during commissioning and qualification at all sites within the region.
- Develop and ensure the implementation of a Regional strategic Qualification Master Planning process in close cooperation with Regional Quality and the Sites.
- Guide and support the Site Engineering Services and Project Management Teams in all aspects of C&Q planning and execution in Capital projects and operations.
- Facilitate discussion with local and regional Engineering and Quality Teams to optimize resource utilization and timelines without compromising results in C&Q as well as validation activities.
- Support a strong implementation of Good Engineering Practices, GMP standards and compliance to applicable regulations in C&Q activities in the region.
- Provide guidance to site and regional project management teams in GxP compliance from project initiation till handover to facilitate positive C&Q and validation results.
- Support the site teams in developing and optimizing the respective site qualification Master Plans.
- Ensuring the sharing and application of best practices.
- Review site adherence to C&Q Global Standards.
- Facilitate the implementation and optimization of site re-qualification approaches and plans in close cooperation with local Quality, Engineering and operation teams.
- In cooperation with procurement, develop optimized regional sourcing strategies for C&Q services.
- Close collaboration with regional and global engineering and quality teams.
- Foster a professional network (internal and external to Takeda) constantly assessing and seeking best practices for use at the site and for the broader Takeda network. Active participation at ISPE or similar networks is encouraged.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Degree in engineering (mechanical / process / chemical) or pharmaceutical science (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent
- Languages: Fluent business level English capability
Fluent Japanese writing and verbal communication skills required
- Experience: At least 10 years in Commissioning & Qualification or GMP regulated project management or operations, including 5+ years as C&Q lead of sizeable investment projects in the pharmaceutical industry.
- High communication skills, analytical mind-set, ability to work under pressure
- GxP/QA knowledge
- Innovative thinking
- Building relationships and teamwork
- Strong know how in qualification and validation processes
- Can establish and coordinate service contracts with C&Q providers
[Additional desired Skills]
- Experience in Manufacturing or operations
- 賞与: 原則年2回
Empowering Our People to Shine
Osaka (Juso), Japan
Job ID R0010669