Apply on Employer Site

Tigermed · 10 hours ago

QA Director

United States

Full-time

Remote

Director/Executive

8+ years exp

Tigermed is a clinical research organization that is seeking a QA Director to oversee quality assurance activities within the QA department. The role involves implementing quality management strategies, maintaining compliance with regulations, and driving continuous improvement in QA processes.

BiotechnologyClinical TrialsHealth CarePharmaceutical

Responsibilities

Under direction of QA head or line manager, implements the quality management strategy of Tigermed Group, maintains quality standards related to business operations, and defines business process management frameworks

According to the assignment, to ensure the implementation of quality management strategies and promotion of business operations quality standards in respective functions or subsidiaries

Supports QA head or line manager to oversee and maintain subsidiaries QMS in order to demonstrate such system and process are implement in compliance with Tigermed quality standards

According to business needs, performs effective audit and evaluation to Quality Management System and quality of clinical research conducted by Tigermed and subsidiaries. In case need, participate in audit peer review and discussion. Review and confirm audit result for audits delivered by subordinates if have

Participates in and drives the efficient operation and standards development of Tigermed QA department, makes efforts to contribute to continuous optimization and improvement

Builds up QA department knowledge management framework. Strategically design QA professional knowledge pool and QA talent development plan

Leads development and maintenance of QA professional improvement plan, as well as design professional skill training program

To maintain and update QA internal information sharing platform

Oversees subordinates according to QA team development needs, includes performance management, personal development, provides training/coaching and other development opportunities, drive and ensure the smooth achievement of team objectives

Completes other tasks assigned by QA head or line manager

Qualification

Quality Management System (QMS)ICH-GCPGCP certificateDrug/device developmentClinical research experienceMicrosoft OfficeAnalytical skillsFluent in EnglishFluent in MandarinCommunication skillsLeadership skills

Required

Bachelor degree or above in a biomedical/pharmacy/nursing/healthcare discipline. For those who have excellent experience and learning skills can be considered

Adequate knowledge of drug/device development life cycle and related process

Adequate knowledge of Quality Management System (QMS), ICH-GCP & Chinese GCP and local regulation

A GCP certificate is required

At least 14 years of relevant experience in clinical research including direct field monitoring experience or at least 8 years of quality management relevant working experience, with a demonstrated record of accomplishments

Fluent in both written and oral English, Mandarin

Good at Microsoft offices

Good analytical, communication, interpersonal, organizational planning and presentation skills

Demonstrates ability to seek innovative solutions

Good sense of leadership and be good at reasonable contemplation

Self-motivated and result driven