QA Director

Overview

• Oversight XDC SG site quality assurance.
• To ensure company in compliance with all applicable global regulations and guidance.

Job Responsibility

1. Provides strategic and scientific leadership, making critical decisions on aspects of the Risk Based Quality Management System (QMS).
2. Provides oversight, leadership, and direction for functions of Clinical, CMC and manufacture of all SG site from QA/quality perspective.
3. Leads GMP compliance team, hosts the regulations compliance inspection, including but not limited to inspection from FDA, EMA, JP, etc.
4. Oversees the execution of the QA strategy as defined in the Quality Manual for all worldwide regulated activities.
5. Oversees the development, governance, adherence, and reporting of appropriate processes for global procedural practices in alignment with the QMS.
6. Promotes quality improvements based on compliance trends to established quality standards and measurements.
7. Serves as a subject matter expert for GMP quality principles.
8. Maintains a contemporary knowledge of current industry trends, standards, and methodologies as they relate to GMP and Quality Management Systems.
9. Oversees the development of content for GMP training as necessary both internally and externally.
10. Contributes to company success through both internal and external interaction with stakeholders, regulatory agencies, and partners as appropriate.

Requirement:

1. Min Degree in any discipline, PhD is an added advantage, with 15+ years of pharmaceutical or biotechnology industry experience.
2. Multiple years of management experience and comprehensive knowledge of functional departments including R&D QA, GMP QA, CMC QA, and Manufacture QA. Experience in international pharmaceutical groups.
3. A thorough knowledge of drug regulatory laws and regulations, including GMP regulations, as well as experience in FDA and EMA inspections.
4. Expertise in Quality Management. Professional knowledge in Biology or Biotechnology preferred.
5. Able to identify and implement methods, techniques, procedures, and evaluation criteria, and to guide the successful completion of major programs and projects.
6. International strategic vision and excellent communication skills.