Job Title: Quality Assurance Director- Compliance Management
Report to: Vice President, Quality Assurance Department
Location: Los Angeles
RemeGen Biosciences focuses on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases. We leverage our deep insights into human biology, advanced protein engineering and design technologies, and rich experience in manufacturing and clinical development to uncover novel therapeutic targets and develop best-in-class and first-in-class biotherapeutics.
The QA Director provides quality oversight, compliance management, and process supervision of contract manufacturing/analysis of overseas projects in RemeGen's commercialized quality system. This role participates in overseas-related audits, tracking foreign relations, policies, and guidelines, providing an interpretation of such work at internal trainings.
- Responsible for compliance management and process supervision of contract manufacturing/analysis of overseas projects in RemeGen's commercialized quality system, including attending relevant meetings, coordinating and dealing with overseas-related quality issues, compliantly handling quality events during contract manufacturing/analysis, and assisting in organizing release work. Promote the resolution of overseas-related cross-departmental quality issues. Participate in the writing of overseas application materials. Perform audits of overseas suppliers/service providers. Participate in the overseas related external audit, assist in solving the problems found in the audit and inspection, and complete the audit responses. Track foreign regulations, policies, and guidelines, organize interpretation of regulations, policies, and guidelines, and conduct internal training. Participate in various quality management activities of the commercialized quality system, regularly share the cases of quality management activities, and promote continuous improvement of the commercial quality management.
- Master's degree or above in biopharmaceutical-related majors. At least 10 years of working experience in biopharmaceutical commercialized quality management, familiar with FDA, EU, and other overseas regulations, with FDA and EU certification inspection experience. Excellent written and oral communication skills and experience in quality management in biopharmaceutical companies will be preferred. Strong ability in cause analysis, risk assessment, and proactive identification of quality issues. Strong communication and presentation skills, project management, and organization skills. Excellent team support skills, ability to analyze and solve complex problems, lead and solve cross-departmental issues.
Remegen Biosciences is an equal employment opportunities (EEO) employer.