|部署・役職名||QA Director / Sokatsu|
Roles ＆ Responsibilities （職務内容）
Responsibilities as Director QA:
Responsible for quality oversight and regulatory compliance of products marketed in the country, including product release and Quality aspects of the product life cycle management.
Responsible for quality approval and management of 3rd party service providers/suppliers/manufacturers/distributers.
To overview, support and provide guidance for manufacturing plants, local and overseas, so that they can perform appropriate manufacturing and quality control, in accordance to the current GQP Ministerial Ordinance.
To create, maintain and continuously improve Quality procedures, in accordance with our Quality Policies and SOPs, as well as with Local Requirements, to ensure the Quality, Safety and Compliance of our products and services.
To analyze and provide disposition on Quality processes （not limited to）: Changes impacting GxPs, Quality Deviations, Quality parts of Regulatory submissions, Customer Complaints, Quality Technical Agreements, Field Actions, Supplier Qualification and Approval.
To provide support and/or be part of our “Sanyaku”.
To represent Quality Division in internal/external meetings and committees, including Quality related projects and associations.
To appropriately perform talent management in order to hire, manage, develop and retain talents within the department.
To manage the department’s resources, according to the approved budget.
Responsibilities as Soseki－総括製造販売責任者）
Shall provide necessary recommendations and directions to MAH regarding MAH’s quality assurance and safety management duties.
Supervise and instruct Quality Assurance Officer and Safety Management Officer to conduct quality assurance duties and safety management duties fairly and appropriately based on their procedures.
Review and/or approve the GQP and GVP procedures.
Represent MAH in internal/external meetings and committees as necessary
Full time employment
Working hours 9:00 to 17:30 （7 hours 30 minutes working hours） 1 hour break
Legal welfare （health insurance, long－term care insurance, welfare pension, employment insurance, workers' accident compensation insurance）
Retirement allowance system
Childcare / long－term care （maternal health management time （paid）, nursing time （paid）
Prenatal and postnatal leave system, maternity allowance, maternity and childcare lump sum, childcare leave benefit, nursing care leave benefit
Childcare leave system, reduced working hours system, nursing care leave system, nursing leave, nursing care leave）
Illness / disability （sick leave, leave system, term life insurance for general welfare organizations, long－term disability income compensation insurance, workers' accident compensation insurance）
Saturdays and Sundays （complete weekly two－day system）, public holidays
Year－end and New Year holidays （December 29－January 4）
Summer vacation （3 days）
Annual paid leave （4－11 days in the first year, 11 days in the next year, maximum 20 days）
Sick leave （1－5 days in the first year, 6 days after the next year）
Anniversary vacation （1 day）
【歓迎（WANT）】Requirement Experiences, Skills, ＆ Knowledges:
10＋ years of experience in related Quality leadership position, covering GxP within the pharmaceutical industry or other similarly regulated industry.
Deep knowledge of ICH, GQP/GMP regulations.
Strong communication and presentation skills; able to interface at all stakeholder levels.
Strong negotiation skills, able to interface with business related authorities and partners.
Strong people leadership skills including the ability to effectively manage, develop and mentor employees.
Capable of performing well under pressure with a positive attitude and optimism.
Demonstrated interpersonal orientation with assertiveness and sensitivity to others.
Demonstrated management skills with organizing, planning and controlling resources.
Proficiency in speaking, comprehending, reading and writing English and Japanese.
Pharmacist License, valid in Japan （Must Requirement）.