QA Head Hinseki

1. JOB PURPOSE
   

The Quality Responsible Person （品質保証責任者） as stipulated in Good Quality Assurance Practice (GQP) in Japan shall manage and direct the quality affairs of the company, in order to maintain marketing authorization and adhere to regulatory requirements related to quality assurance for the company and for its products in Japan.

The Quality Responsible Person （品質保証責任者） shall represent the company in terms of quality assurance supporting the Supervisor General, Sokatsu（総括製造販売責任者）.

1. KEY RESPONSIBILITIES/ACCOUNTABILITIES
   

∙ Function as Hinseki （品質保証責任者） stipulated in GQP to support the Sanyaku (three officers in MAH) organization within the Japan office

∙ Lead the preparation and execution of Quality Management activities for Japan

∙ Acts as key contact person to Affiliate & In-Market QA

1. DETAILED RESPONSIBILITIES/ACCOUNTABILITIES
   

∙ Responsible for GQP compliance management and execution of necessary actions including organization management

∙ Manage and ensure oversight of the QA processes including, but not limited to, Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or Stability Data Review, Validation, Change Control Management, Training and Distribution.

∙ Manage quality evaluation of contracted warehouse operations, manufacturing sites, and external laboratories

∙ Provide support to routine activities, projects, development and training relevant to area of expertise where required

∙ Support continuous improvement activities regarding areas of responsibility

∙ Engaging assessment regulatory impact on product quality and manufacturing processes.

∙ Analyze and communicate proposed, new or changing requirements and for their implementation, ensuring business goals are met. Includes liaison with other functions, industry bodies or regulators as required

∙ Engage with the Affiliates & In-Market Quality team to ensure global quality management objectives, KPI reviews, knowledge sharing, and localisation requirements

∙ Identify, assess and manage regulatory risk proactively and provide senior management in the MAH with key data to help drive decisions

∙ Engaging site inspections, preparing audit observations response as necessary

∙ Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters

1. KEY ATTRIBUTES/SKILLS/EDUCATION – ESSENTIAL
   

Attributes

∙ Minimum 10 years of related pharmaceutical industry regulatory experience

∙ At least 5 years of QA experience in a pharmaceutical manufacturing environment (at least 3 years in a supervisory or managerial role)

∙ In-depth knowledge of ICH requirements and Japan regulatory requirements, especially in CMC.

∙ Proficient with eQMS and eDMS systems

∙ Ability to identify root cause of problem and creatively problem solve to gain resolution

∙ Ability to prioritize and handle multiple projects simultaneously.

∙ Ability to negotiate and communicate with internal and external customers

∙ Good sensitivity of potential risk and risk management in business compliance and quality

∙ Technical transfer experience for QC test or manufacturing process for sterile products

∙ Experience of CA/PA planning and execution

∙ Demonstrate evidence of a professional qualification for Hinseki （品質保証責任者） stipulated in GQP :

o Experienced in the quality assurance duties or other similar duties for at least three years

o Competence in conducting the quality assurance duties correctly and efficiently

o Not to hinder the proper and efficient conduct of the quality assurance duties

∙ In-depth knowledge of ICH requirements and Japan regulatory requirements, especially in Quality.

∙ Ability to identify root cause of problem and creatively problem solve to gain resolution

∙ Ability to prioritize and handle multiple projects simultaneously.

∙ Ability to negotiate and communicate with internal and external customers

Skills

∙ Ability to create Japanese QA related documents with communication skills with multiple stakeholders both internally and externally including Japanese Health Authorities.

∙ Demonstrated experience in effective communication

∙ Strong negotiating skills and ability to think creatively and develop creative solutions.

∙ Native level in Japanese and sufficient English level (speaking & writing English) to achieve communication/discussion with global team is required

∙ Excellent oral and written communication skills, liaising with multiple stakeholders both internally and externally including Japanese Health Authorities

∙ Excellent leadership skills and ability to work in a team

∙ Education Required: BS Degree in scientific disciplines, MS/PhD preferred

∙ Strong PC literacy is required; MS Office skills (Outlook, Word, Excel, PowerPoint)

1. KEY ATTRIBUTES/SKILLS/EDUCATION – DESIRABLE
   

Attributes

∙ Experience of leading Japan Health Authority interactions related to Quality Issues. (preferable)