TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Clinical QA Manager

Department :  CD&RA
Working place :  Beijing
Recruitment :  1
Nature of work :  Full-Time
Working years of :  5+ years experience
Minimum academic :  Bachelor
Release time :  08 Jul, 2021
Job Responsibilities
  • 1. Perform/coordinate GCP related audits of investigator sites, vendors, regulatory documents.

  • 2. Coordinate/perform internal quality system audits applied to clinical development activities.

  • 3. Verify the compliance with the applicable regulatory requirements and guidelines concerning the Quality

  • 4. Ensures appropriate and timely escalation of quality issues, to the line manager.

  • 5. Provides inspection management support as appropriate.

  • 6. Maintain a Database for vendors and investigational sites audits.

  • 7. Acts as a strong technical resource to resolve GCP issues based on knowledge of relevant SOPs, GCP, applicable local regulations & guidelines.

Job Requirements
  • 1. Broad knowledge of the drug development process, GCP guidelines, and applicable regulations.

  • 2. Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.

  • 3. Familiarity with existing company systems, policies and procedures and knowledge of multiple therapeutic areas and nonclinical study conduct is desirable.

  • 4. Able to work independently

  • 5. Able to communicate the audit findings to stakeholders in both verbal and written formats.

  • 6. Strong interpersonal skills with the ability to work effectively in teams.

  • 7. Able to work for multi-task and manage time efficiently and effectively.

  • 8. Able to work in a culturally diverse environment.

  • 9. Education/Experience: BS/BA degree in relevant area with experience in clinical operation, project management field and experience in the pharmaceutical industry including experience of audits is preferable