Job Purpose & Main Responsibilities

・Internal (head office, quality assurance department, and GSK network sites) and external (mainly non-GSK MAH contractors) communication to achieve product quality assurance and execute quality assurance tasks.

・Lead compliance with site GMP regulations, pharmaceutical law, and GSK QMS.

・Manage the Compliance department.

• Create and implement education plans for staff on GxP-related and non-GxP topics.
• Allocate resources for Compliance department to maintain and improve site QMS.
• Create department targets aligned with the factory's targets and achieve GSK GSC targets.
• Improve quality management processes and systems, and maintain and ensure quality.
• Obtain approvals for QMS processes (document management, education management, quality agreements, supplier management, DI, specification setting, vaccine national inspection, system management, change management, etc.) in the Compliance department, as needed, and obtain approvals for related GMP documents from the quality assurance department.
• Summarize discussions with authorities (particularly the Tochigi Prefectural Pharmaceutical Affairs Division) as needed.
• Comply with GMP and legal requirements by summarizing internal audits, self-inspections, and audits by social groups and external regulatory authorities.
• Support NPI activities to introduce correct quality products to the market.

・Contribute to the maturity of site quality culture as a member of the Site Quality Leadership team.

・As a manager, engage in activities to build, maintain, and improve the site's continuous improvement culture.

※The scope of job duties and work location is as determined by the company.

Required Skill, Experience, Etc.

Required

Skills

・Understand QMS/EHS overview.

・Have knowledge of pharmaceutical law and GMP regulations.

・Have knowledge and sufficient understanding of product manufacturing management and quality management.

・Have knowledge of GMP, quality, compliance, QMS, pharmaceuticals, and manufacturing processes.

Experience

・Have experience in manufacturing management or quality management for more than 3 years.

Education/Qualifications/Language

・Bachelor's degree or equivalent knowledge/experience.

・Have communication skills in Japanese.

・Have business English skills.

Preferred

Skills

・Have a strong sense of responsibility.

・Have high adaptability and ability to adapt to change.

・Have a desire for continuous improvement.

Experience

・Have human resource management ability, mentoring, and coaching ability.

Education/Qualifications/Language

・Have knowledge of chemistry/pharmacy.

・Have a pharmacist license.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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