Takeda

Associate Director, Clinical Quality Assurance, TDC-J

Takeda

full-time

Posted on:

Location Type: Office

Location: Osaka • 🇯🇵 Japan

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Provides leadership and guidance to the CQA Program Managers and partner with key stakeholders that are integral to clinical development activities, as applicable.
  • Contributes to the design and implementation of Takeda’s risk-based GCP audit and compliance oversight activities.
  • Monitors effectiveness of GCP processes through risk-based audits and GCP compliance activities and provide actionable data to Senior Management based on identified compliance issues and trends.
  • Oversees and provides necessary support for the GCP components of regulatory Inspections.
  • Establishes strong partnership/relationship with business stakeholders
  • Develops and implements a strategic audit plan in collaboration with Global CQA Leaders.

Requirements

  • BA/BS degree required; advanced degree preferred.
  • Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
  • Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
  • Minimum 5 years leading teams in a matrix cross-functional team.
  • Languages: Japanese (native level), English (business level).
Benefits
  • Allowances: Commutation, Housing, Overtime Work etc.
  • Salary Increase: Annually
  • Bonus Payment: Twice a year
  • Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
  • Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
  • Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
  • Flexible Work Styles: Flextime, Telework
  • Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GCPQuality Assurancerisk-based auditscompliance oversightclinical trial experiencestrategic audit plan
Soft skills
leadershipguidancepartnershiprelationship buildingcollaboration