QA Operations Manager CAR T at Top Global Bio-Pharma

Tokyo 23 Wards Permanent ¥10,000,000 - ¥14,000,000 Foreign Multinational
  • Be part of one of the top global pharmaceutical companies in the industry
  • Manage the innovative cell therapy product manufacturing

About Our Client

  • One of the top international pharmaceutical companies in the industry
  • Innovative pipeline including oncology, immunology, hematology, and cardiovascular disease
  • Progressive company structure prioritising patient and employee centric ideals



Job Description

  • Provide efficient quality oversight in the operations at CMOs in the support of the company's cell therapy product manufacturing
  • Work with cross functioning teams to lead the manufacturing operations and ensure proper accordance to approved regulatory submissions, quality agreements, and necessary regulatory requirements
  • Review and approval of CMO deviation investigations, CAPA, and controlled documentations
  • Be the lead impact assessor in the reviewing/approving CMO changes
  • Support in the data auditing and review of protocol in the support of regulatory submissions
  • Partner with global quality systems to ensure efficient implementation to company audits



The Successful Applicant

  • Bachelors or Masters in biochemistry, biology, microbiology, chemistry, engineering, pharmacy, or related field
  • At least 5 years experience in regulated function (cGMP/GCP/GCTP) with background in QA
  • Knowledge of relevant regulations and guidance
  • High fluency in Japanese and English
  • Experience in cell therapy and commercial products is a plus

What's on Offer

  • Competitive salary and benefits
  • Amazing work life balance
  • International work environment
  • Amazing career progression in QA
  • Work with key industry individuals solving unmet medical demand
Contact
Zach Itozu
Quote job ref
4216709
Phone number
+813 6832 8683

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
4216709
Company Type