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Location
Tokyo
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-179276
Contact
Yin Yin Pui
Contact email
Email Yin
Contact phone
+65 6692 0751
Posted
大约 3 小时 前
Employment: 20-30% domestic and international travel

Industry: Pharmaceutical / Drug Development


About the Role:

This role oversees the CQA in Japan and ensure alignment to global strategic objectives. You will provide clinical development quality oversight to sponsors, drive risk based GCP audits, rectify critical risk compliance, implement timely CAPAs closures, and communication to senior management. Be the corporate representative for drug development inspection by health / regulatory authorities.


Responsibilities:

  • Leads and manages the Japan CQA function (including development, execution, process review) to maintain sponsor’s oversight of the firm’s R&D activities in compliance with the regulatory requirements
  • Serve as the SME and strategic GCP resource to front the company for drug development activities, and to lead the preparation and responses to health / regulatory agencies’ inspection; and provide guidance to key stakeholders in support of critical decision making related to risk management matters
  • Work closely with internal (e.g. R&D Quality, Global Quality, R&D operational functions) and external (suppliers of outsourced services) stakeholders to ensure clinical trials are conducted in compliant with local regulations, ICH-GCP and corporate adopted regulatory guidelines
  • Collaborates with CQA Supplier Quality to assess suitability of new vendors as well as ongoing evaluation of overall compliance performance of vendors
  • Ensure Japan’s sites ICH-GCP inspection readiness through QA programs related activities, provide strategic direction, and manages health authority GCP sponsor & investigator routine and pre-approval inspection readiness


Requirements:

  • BS/BA Degree or higher, with RQAP-GCP registration/certification preferred
  • Well-versed in GCP and understanding of Japan and global clinical development
  • 12 years industry experience in CAQ and/or Clinical Operations; advanced experience in GCP auditing required
  • 7 years in people management capacity, managing teams in a matrix team environment preferred
  • Seasoned in the conducting and reporting of audits, translation of findings into CA plans to mitigate corporate risks, patient safety and data integrity
  • Proficiency in interpreting common scientific/technical journals, financial reports, and legal documents; and articulate these information to senior management, internal and external stakeholders in a succinct matter
  • Excellent communicator with good problem-solving skills
  • Language Skills: Native Speaking Level Japanese, Business level English (verbal/written)


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