メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - 品質保証
メディカル・バイオ - 品質管理

◆OBJECTIVES/PURPOSE
Change the business in line with standard site Quality Organizational Model:

・Provide leadership across the Quality organization to promote and drive strategic thinking and innovative approaches to change the business
・Drive and lead various change/transformation and continuous improvement initiatives and facilitate development of Quality Strategies to ensure a harmonized and integrated quality approach that will provide oversight and governance to enable Site Quality to successfully change the business
・Build and promote a Quality Culture through collaboration and partnerships, innovation, continuous improvement, and a learning environment that includes knowledge and best-practices sharing
・Leverage science, systems, and people as key elements to direct the Quality Culture that focuses on patients, including regulatory compliance, patient safety, continuous improvement, pro-cess efficiency, and problem prevention
・Responsible for a timely and effective communication and escalation process to Site Quality Head in order to raise quality and safety issues
・Responsible for the department expenses and department budget planning
・Ensures adherence to EHS program

◆ACCOUNTABILITIES

【Strategy】
・Lead and facilitate development of strategies for an integrated quality approach & culture in the organization
・Drive and coordinate Quality projects, initiatives, process improvements and best practice sharing across the Site quality organization; including appropriate tools and training
・Provide executive sponsorship to Quality Initiatives to ensure initiatives stay on track and deliver results
・Build and lead strong foundation for collaboration and ensure management of interdependencies across the organization with all internal business partners

【Services】
・Lead overview on budget and resource management for the Site Quality Leadership
・Lead and manage external influencing activities to track leadership involvement in key external industry & regulatory groups and maintain strong networks with industry groups and contacts in order to stay current with industry best practices and trends

【応募要件】
■Technical/Functional (Line) Expertise
・Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines.
・Knowledge in API, solid dosage forms, parenteral technology, biologics or combination products.
・Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations.
・Excellent verbal and written communication skills in both Japanese and English.
・Adaptive communication and presentation skills to effectively reach different levels, including senior management.
・Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
・Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred.

■EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
・Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.
・At least 10 years of management experience in the following areas in the pharmaceutical industry: Quality assurance, Quality Control; understanding of the requirements for manufacturing, plant utilities, computer systems and project management.
・In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
Well-knowledge related to Manufacturing, Finance, EHS and HR (incl. Labor law)
・Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)
・Business level of English skill is necessary (both verbal and written)

【Preferred】
・License for pharmacist
・Lean-6-sigma certification
・MBA
・Experience of overseas assignment.
・Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety. (5 years for department head and 3 years for Group Managers)
・Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.

■ADDITIONAL INFORMATION
・Some travels will be required.
・This job description is not designed to be a complete list of all duties and responsibilities required of the position.

■職種未経験者：不可