Manager/Senior Manager/Director of QA/RA
This Quality Assurance (QA) / Regulatory Affairs (RA) personnel will manage, coordinate and evaluate the company quality system and regulatory affairs. These activities include the development, implementation, and monitoring of quality programs and policies that ensure the development manufacture of the drug product/drug substance and instruments in compliance with corporate policies, government regulations (e.g. 21 CFR), applicable industry guidance (eg, ICH), etc. In addition, the QA/RA personnel will be responsible for submission of documents to global Regulatory Agencies.
Essential Job Responsibilities
- Direct the activities of the Quality Department (Quality Assurance, Quality Control) to ensure compliance with all appropriate regulations and standards.
- Ensures the quality systems to be established, implemented and maintained in compliance with all applicable Regulations.
- Oversee, conduct or manage internal audits, CMO/CRO/vendor audits and CMO/CRO/vendor qualification, corrective and preventive action system, nonconforming materials, Material Review Board, and calibration program.
- Provide document control, including but not limited to: issuance of all QA assigned numbers, creation and issuance of logbooks, routing and tracking of new and revised documents for approval, the filing of controlled documents and other documentation.
- Support CMO/CRO manufacturing activities, including but not limited to: batch record review and release, and other GMP activities.
- Conduct internal audits and training, including but not limited to execution of assigned internal audits and training, identifying and implementing corrective and preventative actions.
- Oversee product quality reviews, management reviews, and preparation of quality reports.
- Ensure dependable and timely results from quality control, to support process control and process changes in compliance with requirements.
- Participate or lead FDA inspections.
- Manage the assembly, publishing, and submission, of documents to FDA and other agencies.
- BS/MS/Ph.D. in life science, chemistry, pharmaceutical science or related field.
- Minimum of four (4) years of related professional experience in QA/RA position. Experience in GMP manufacturing environment.
- Excellent problem-solving and analytical skills applied to investigations.
- Excellent project management, time management, and multi-tasking skills.
- Excellent written and verbal communication skills.
- Experience in electronic submission a plus.
- Experience in FDA audit a plus.
Zensun USA, Inc. is a clinical-stage biopharmaceutical company. It is devoted to the research and development of new drugs through self-owned intellectual properties. Currently, we have a lead candidate, Neucardin that is in Phase 2/3 clinical development in the United States of America and Phase 3 clinical development in China for the treatment of Chronic Heart failure. Zensun USA is seeking a highly-motivated professional who is looking to grow their career with our company.