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Senior QA Director
- World leading company platform
- Attractive package
About Our Client
world leading CRO company
Define the strategy for quality management in Company. GLP Laboratories including process reengineering or continuous process improvement and quality training
Develop, implement, and maintain a quality management system for Company. GLP Laboratories assuring compliance with all applicable internal policies and health authority regulations
Support the development and implementation of a Company. GLP-wide quality system
Drive the expansion of GLP principles and international laboratory quality standards (e.g. ISO) to other laboratory areas in Company. as appropriate
Develop and update Quality Manual for Company. GLP Laboratory areas
Maintain an active dialog with all levels of laboratory personnel and line management on purpose, direction, and goals of quality management.
Evaluate, assess and ensure adherence to Good Laboratory Practice (GLP) regulations for preclinical safety studies and bioanalytical support for clinical studies intended for submission to regulatory agencies worldwide
Ensure regulatory trends are monitored and communicated to all GLP areas
Assure adequate QA support and oversight for all GLP areas and other selected laboratories to ensure adherence to high quality standards and compliance with all applicable regulatory requirement
Assure health authority inspections are fully supported
Approve GLP QA Suzhou SOPs
Ensure consistent inspections practices of QA operations within China
Maintain appropriate QA contact with health authorities as well as public and private institutions regarding GLP compliance matters and international quality standards
Monitor local projects so that work is on course to meet regulatory or client submission dates
Oversee local QA work prioritization and resource management
Oversee and support local QA heads in all operational aspects as appropriate. Provide local QA groups with general direction and guidance.
The Successful Applicant
Degree in Natural Sciences or Medicine or related experience
Extensive experience in medical or preclinical Research & Development
Understanding of Quality systems and global regulatory (GLP) requirements
Strong communication and negotiation skills
Excellent interpersonal and leadership skills
PhD is desirable.
At least 10-year pharmaceutical or CRO industry experience.
Ability to work independently and collaboratively.
What's on Offer
Great platform with Attractive package