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Job Summary:
- Oversight XDC SG site quality assurance to ensure company in compliance with all applicable global regulations and guidance.
Job Responsibility:
- Provides strategic and scientific leadership, make critical decisions on aspects the Risk Based Quality Management System (QMS).
- Provides oversight, leadership, and direction for functions of Clinical, CMC and manufacture of all SG site from QA/quality perspective.
- Leads GMP compliance team, host the regulations compliance inspection, including but not limited to inspection from FDA, EMA, JP and etc.
- Oversees the execution of the QA strategy as defined in the Quality Manual for all worldwide regulated activities.
- Oversees the development, governance, adherence and reporting of appropriate processes for global procedural practices in alignment with the QMS.
- Promotes quality improvements based on compliance trends to established quality standards and measurements.
- Serves as a subject matter expert for GMP quality principles.
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as they relate to GMP and Quality Management Systems.
- Oversees the development of content for GMP training as necessary both internally and externally.
- Contribute to company success through both internal and external interaction with stakeholders, regulatory agencies, partners as appropriate.
Job Requirements:
- PhD is a plus, with 15+ years of pharmaceutical or biotechnology industry experience.
- 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.
- A thorough knowledge of drug regulatory laws and regulations. Including GMP regulations, as well as experience in FDA and EMA inspections.
- Expertise in Quality Management. Professional knowledge in Biology or Biotechnology preferred.
- Able to identifies and implements methods, techniques, procedures and evaluation criteria, and to guide the successful completion of major programs, projects.
- International strategic vision and excellent communication skills.
Job Summary:
- Oversight XDC SG site quality assurance to ensure company in compliance with all applicable global regulations and guidance.
Job Responsibility:
- Provides strategic and scientific leadership, make critical decisions on aspects the Risk Based Quality Management System (QMS).
- Provides oversight, leadership, and direction for functions of Clinical, CMC and manufacture of all SG site from QA/quality perspective.
- Leads GMP compliance team, host the regulations compliance inspection, including but not limited to inspection from FDA, EMA, JP and etc.
- Oversees the execution of the QA strategy as defined in the Quality Manual for all worldwide regulated activities.
- Oversees the development, governance, adherence and reporting of appropriate processes for global procedural practices in alignment with the QMS.
- Promotes quality improvements based on compliance trends to established quality standards and measurements.
- Serves as a subject matter expert for GMP quality principles.
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as they relate to GMP and Quality Management Systems.
- Oversees the development of content for GMP training as necessary both internally and externally.
- Contribute to company success through both internal and external interaction with stakeholders, regulatory agencies, partners as appropriate.
Job Requirements:
- PhD is a plus, with 15+ years of pharmaceutical or biotechnology industry experience.
- 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.
- A thorough knowledge of drug regulatory laws and regulations. Including GMP regulations, as well as experience in FDA and EMA inspections.
- Expertise in Quality Management. Professional knowledge in Biology or Biotechnology preferred.
- Able to identifies and implements methods, techniques, procedures and evaluation criteria, and to guide the successful completion of major programs, projects.
- International strategic vision and excellent communication skills.