Sr Clinical Quality Specialist

Takedajobs

Mumbai, India
Clinical quality management systems
Gcp compliant process development
Supplier and clinical study audit
Responsible for managing the clinical quality function, ensuring compliance with local clinical trial regulatory requirements and Takeda’s Quality Management Systems

Job Summary

  • Responsible for managing the clinical quality function, ensuring compliance with local clinical trial regulatory requirements and Takeda’s Quality Management Systems.
  • Drives the development and implementation of CQA procedures and local QMS, leads supplier and individual clinical study audits, and provides independent quality and compliance oversight for GCP suppliers.
  • Provides GCP guidance to internal and external stakeholders, supports regulatory inspections, and manages relationships with local regulatory authorities.

Matching Summary

Responsible for managing the clinical quality function, ensuring compliance with local clinical trial regulatory requirements and Takeda’s Quality Management Systems.

Skills & Requirements

Must-have

  • Clinical Quality Management Systems
  • GCP compliant process development
  • Supplier and clinical study audit
  • Quality Incident Notification
  • Risk assessment and mitigation
  • GCP guidance and document review

Nice-to-have

  • Collaboration and stakeholder management
  • Organizational agility and change leadership
  • High-performance culture
  • Innovation and trend understanding

Key Requirements

  • 7-10 years experience in clinical trial industry
  • Life Sciences Graduate/Postgraduate degree
  • Ability to work independently
  • Fluent in English

Work Rights

Not specified

Tailored Resume

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