Job Description

Be part of one of the top global biopharmas in the industry. Take lead in the overall improvement of clinical QMS.

Description

*

Leads Quality Planning & Implementation: Oversees all quality activities within Japan Development Operations (J-DO), ensuring alignment with global Clinical Quality Management Systems and adapting to regulatory and organisational changes.
*

Ensures Inspection Readiness: Guides study teams and collaborates with stakeholders to maintain a constant state of readiness for regulatory inspections (e.g., PMDA, EMA, FDA).
*

Drives Continuous Improvement: Collects and analyses quality data, leads issue investigations and CAPA development, and identifies opportunities for quality and process improvement.
*

Fosters Global Collaboration & Compliance: Acts as a global quality representative, ensuring consistent process application, managing compliance risks, and integrating regulatory updates into J-DO operations.
*

Champions Quality Culture: Serves as a professional role model, promotes ethical behaviour, simplifies procedural documentation, and builds strong relationships with internal and external partners.

Profile

* University degree in scientific or related field
* High fluency in English and Japanese (non-native level speakers will not be selected)
* Extensive experience in the pharmaceutical industry specifically in clinical QA
* Ability to understand quality systems aligned with GCP
* Knowledge in local regulations and compliance

Job Offer

* Competitive salaries and benefits
* Great work life balance
* Hybrid working style and international environment
* Amazing career progression in clinical QA
* Work with industry leaders who are solving various unmet medical needs

Page Group Japan is acting as an Employment Agency in relation to this vacancy.

Job Tags

Similar Jobs