About the job
Join Kyowa Kirin, a rapidly expanding global specialty pharmaceutical company dedicated to harnessing cutting-edge biotechnologies to innovate and provide groundbreaking therapies across four critical disease areas: bone and mineral disorders; intractable hematologic conditions; hematology oncology; and rare diseases. With our headquarters located in Princeton, New Jersey, and additional offices in California, North Carolina, and Mississauga, Ontario, we are committed to translating scientific advancements into meaningful treatments, addressing unmet medical needs from drug discovery through to product development and commercialization.
Position Summary:
The Manager of R&D Quality Assurance will oversee Quality Assurance systems and processes, conducting comprehensive internal and external audits, and ensuring adherence to global standards of quality. This role is crucial in supporting the QA program to ensure the accuracy and integrity of scientific data submitted to regulatory authorities for new drug applications and biological licensing agreements. You will collaborate closely with the R&D teams to provide essential quality insights.
Key Responsibilities:
- Act as the primary liaison for GCP/GLP quality concerns, offering continuous feedback to management on potential quality risks. Engage in clinical trials through independent review and approval of deviations and CAPAs, GCP guidance, and the preparation of quality agreements.
- Conduct and document assigned GCP/GLP audits of clinical investigator sites, vendors/CROs, internal systems, and clinical data/documents.
- Prepare timely, high-quality audit reports; assess audit responses; and supervise CAPA development, implementation, and tracking in accordance with corporate standards.
- Maintain in-depth knowledge of global GCP/GLP regulations and industry standards. Serve as a subject matter expert for internal teams, interpreting regulatory requirements, and actively contributing to the Regulatory Intelligence program.
- Design and deliver GCP training sessions to enhance compliance awareness and foster a culture of quality across the organization.
- Support continuous improvement initiatives by developing, revising, and managing SOPs and controlled documents, ensuring effective maintenance within quality document management systems.
- Participate in Health Authority inspections for domestic and international projects as required.
