Clinical Quality Management Associate Director @ Top Biopharma Job at 会社名非公開, 東京都

MnRiRjdpTlpGN3pkaFpqYzMzZzQwOVh3eEE9PQ==
  • 会社名非公開
  • 東京都

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

Nails for You MMP

Esthetician Job at Nails for You MMP

Esthetician, Nails for You MMP. Location 1015 Bronte st. South unit B6Milton, ON. Salary 18.00 to 20.00 hourly (To be negotiated) / 30 to 40hours per week. Full time. Day, Evening, Weekend, Morning. Starts assoon as possible. Benefits: Financial benefits. Languages English...

Sierra Construction Group

Senior Payroll & Benefits Administrator Job at Sierra Construction Group

 ...Overview: The Payroll & Benefits Administrator ensures the accurate and timely processing of payroll for Sierra Construction Group. This role is integral to both the Accounting and HR teams, maintaining compliance with payroll legislation and company policies. The Payroll... 

Rose International

Design Engineer Job at Rose International

 ...Position Number: 482254 Job Title: Design Engineer Job Location: Ottumwa, IA,...  ...Agricultural Engineering Qualifications: Entry-level engineer Ability to work flexible...  ...the State of California Department of Industrial Relations' website here. Rose... 

Kyndryl

Mainframe Technical Specialist Job at Kyndryl

 ...se of this, youll experience variety and growth at Kyndryl that you wont find anywhere else. Youll be involved early to offer solutions, help decide whether something can be done, and identify the technical and timeline risks up fron... 

Centah Inc

Part-time Nights/Weekends, Remote/Hybrid, Customer Service Representative Job at Centah Inc

 ...Job Description Job Description **This is a hybrid position. Work from home status is only granted if criteria is met, and upon completion of 1 week of in-office onboarding/training.** Who is Centah? Acquired by Financeit in 2017, Centah is a lead and workflow...