Clinigen

Global pharmaceutical services and medicine access

Head of Quality Assurance

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeJapanNo salary listed

About the Job

Requirements

At least 10 years of quality assurance work experience in the pharmaceutical industry.
Extensive knowledge of quality assurance, including international aspects.
A bachelor's degree in biology, chemistry, or another life-sciences field.
Confidence dealing with senior management and employees at all levels, with the ability to work and make decisions autonomously.
Experience working with quality assurance databases and Microsoft Office software.
Native-level Japanese and full professional proficiency in English.

Responsibilities

Implement and ensure compliance with quality assurance processes for medical products in Japan, applicable local regulations and standards, global quality assurance registration and standards, and policies and procedures at local, regional, and global levels.
Develop, promote, and audit quality assurance processes and practices to meet Group internal standards and achieve strong external inspection ratings.
Develop continuous quality improvement methodologies and quality assurance offerings that add revenue value and deliver client service meeting commercial and compliance requirements.
Meet all requirements and duties of the statutory titles held, and liaise with Medical Affairs, Regulatory, Supply Chain, Quality, Commercial, Legal, and other functions to provide quality assurance input into product strategic planning throughout the product lifecycle.
Communicate quality assurance concerns and provide feedback about Japan quality assurance activities to the General Marketing Compliance Officer and Global Quality Assurance management.
As the legally stipulated Quality Assurance Manager, oversee all quality assurance activities under applicable local legislation.
Ensure audit and inspection preparation and readiness are understood, and give necessary instructions to each company department.
Ensure the Corrective and Preventive Actions process is understood and perform assigned corrective and preventive action activities.
Ensure compliance with document management procedures for retention and archiving.
Understand and implement the document change management process and serve as the subject matter expert for procedures.
Ensure all training requirements for the role are met and identify stakeholders and ensure they are trained on quality assurance requirements and procedures.
Build alignment and collaboration with Regulatory Affairs, Medical Affairs, Supply Chain, Pharmacovigilance, and Commercial.
Communicate relevant quality assurance compliance concerns to Global Quality Assurance management.
Ensure appropriate implementation of the Business Continuity Plan for third-party agreements.
Ensure appropriate quality assurance language is included in third-party agreements, review agreements regularly for alignment with current regulatory requirements, and reconcile data between third parties and the company.
Respond to regulatory-authority queries related to submissions and archive regulatory correspondence.
Oversee and monitor transfers of product licenses to and from the company to ensure data integrity and ongoing regulatory compliance.
Establish and monitor budgets and forecasts.
Manage and support quality assurance personnel, including hiring, coaching, and developing new personnel.
Provide feedback and regular reports on quality assurance activities to the General Marketing Compliance Officer and Global Quality Assurance management.
Participate in JAPAC or other meetings as the Japan function head when required, and collaborate with applicable departments.
Verify that service providers are qualified to perform outsourced quality assurance activities before work starts.
Write service agreements or quality assurance agreements in accordance with JAPAC and Japan requirements.
Maintain close contact with the contractor company's person responsible for quality assurance implementation to ensure outsourced work is performed properly and smoothly.
Monitor outsourced quality assurance activities for compliance with contract requirements and key performance indicators through quarterly meetings.
Instruct contractors to take necessary actions when outsourced quality assurance activities require improvement.
Develop and monitor key performance indicators in accordance with quality assurance vendor service standards and requirements.

Head of Quality Assurance

Clinigen · Nihonbashimuromachi, Japan (Hybrid) · — · Posted 2026-07-16

Workplace: hybrid

Description

Position summary

Provide leadership and oversight as the Quality Assurance Responsible Person mandated by the Pharmaceuticals and Medical Devices Act, ensuring continued compliance with regulatory requirements and the maintenance of the company's pharmaceutical business license.

Key accountabilities

Implement and ensure compliance to the QA processes for medical product in Japan, in compliance with the local regulations/ standards; Global QA registration/ standards; and policies/ procedure at a local, regional and global level
Developing, promoting and auditing quality assurance processes and practices, ensuring the Group’s internal standards are met and the highest possible external inspection ratings are achieved.
Developing continuous quality improvement methodologies and innovative quality assurance offerings that will add value in revenue growth and that will deliver excellence to clients, exceeding commercial and compliance requirements.
Meeting all requirements and carrying out all duties expected of the statutory titles held. Ensure appropriate liaison with Medical Affairs, Regulatory, Supply Chain, Quality, Commercial, Legal, etc., to ensure Quality Assurance input into the company's strategic planning for products through their lifecycle.
Communicate Quality Assurance concerns with or provide feedback regarding QA activities in Japan to the General marketing compliance officer and Global QA management.

Major Tasks & Activities:

Essential Duties and Responsibilities.

Legally stipulated Quality Assurance Manager
In the capacity of Quality Assurance Manager have an oversight of all QA activities as per applicable local legislation.
Ensure adequate understanding of audit and inspection preparation and readiness. Give necessary instructions to each department of the company.
Ensure understanding of the CAPA (Corrective and Preventive Actions) process. Responsible for performing CAPA activities as per identified roles.
Ensure compliance with document management procedures for retention and archiving.
Understand and implement the document change management process and act as SME (Subject Matter Expert) for procedures.
Ensure all training requirements for the role are met.
Identify appropriate stakeholders and ensure they are trained on QA requirements/ procedures.
Build alignment and collaboration with Regulatory Affairs, Medical Affairs, Supply Chain, PV, and Commercial.
Communicate effectively all relevant QA related compliance concerns with the Global QA management.
Ensure adherence and appropriate implementation of the BCP (Business Continuity Plan) With regards to third party agreements
Ensure the appropriate QA language is incorporated into 3rd party agreements. Perform regular review of the agreements to ensure QA requirements are aligned to the current regulation requirements and perform reconciliation of data between third parties and the company
Respond to submission related queries from the regulatory authorities and archive all regulatory related correspondence.
Oversee and monitor the transfer of product licenses to and from the company to assure data integrity and continued compliance with regulatory requirements.

Team management

Establish and monitor budgets and forecasts.
Manage and support of QA personnel.
People hiring, coaching and development of new QA personnel.
Provide feedback and regular reporting QA activities to the General marketing compliance officer and Global QA management.
As required, participate in JAPAC meeting or other meeting as the Japan function head and collaborate with applicable departments.

Vendor/Third party Management

To verify that the service provider is qualified to perform the outsourced QA activities prior the service starts.
To write the Service Agreement (SA) and or QA Agreement as per JAPAC and Japan requirements.
Maintain close contact with the Person Responsible for Implementation of QA at the contractor company for keeping outsourced work properly and smoothly.
To monitor whether outsourced QA activities are performed in compliance with the contract requirements and KPIs by quarterly meetings.
If the implementation of QA activities outsourced needs to be improved, instruct the contractor to take necessary actions.
Understanding of QA vendor service standards and requirements – ability to develop and monitor key performance indicators

Requirements

At least 10 years of QA work experience in the pharmaceutical industry. (Mandatory)
Extensive knowledge of QA including international aspects.
Bachelor's degree in biology or chemistry or other life sciences
Confidence in dealing with senior management and employees at all levels, especially with the ability to work and make decisions autonomously.
Experience working with QA databases and Microsoft Office software
Native-level Japanese and full professional proficiency in English

Apply

Apply at Clinigen

About the Company

Clinigen

Global pharmaceutical services and medicine access

Clinigen provides pharmaceutical services and medicines to help patients gain ethical access to treatments. It revives niche, hospital-only medicines and offers end-to-end services across the product lifecycle, including clinical trial supply, access programs, and global commercialization. Its three divisions—Clinical Services, Access and Commercialisation, and Lifecycle Services—work with pharma partners to manage regulatory affairs, pharmacovigilance, and market access across more than 100 countries for major pharma clients. The goal is to combine product revitalization with comprehensive lifecycle management to improve patient access worldwide.

Company size: 501-1,000
Company stage: IPO
Headquarters: Branston, United Kingdom
Founded: 2010

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