Manager, R&D Quality Assurance- GCP Auditing
The Manager, R&D Quality Assurance- GCP Auditing at Kyowa Kirin North America is responsible for overseeing quality assurance systems and conducting both internal and external audits to ensure compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards. This role is integral to maintaining the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications. The position is based in Princeton, New Jersey, and involves collaboration with various departments within the organization.
Key responsibilities include serving as the primary contact for GCP/GLP quality issues, performing audits of clinical investigator sites and vendors, preparing detailed audit reports, and overseeing corrective and preventive actions. The manager will also design and deliver GCP training to staff, support continuous improvement initiatives, and participate in health authority inspection activities. Additionally, the role involves contributing to the development and execution of risk-based audit plans and ensuring effective maintenance of quality document management systems.
Candidates must possess a bachelor's degree in Life Sciences or a related field, along with a minimum of three years of experience in drug development within GCP/GLP Quality Assurance. Essential qualifications include hands-on experience in auditing, CAPA management, and deviation review. A strong understanding of global regulatory requirements, including EMA, FDA, MHRA, and ICH guidelines, is required. Experience with electronic Quality Management Systems, such as Veeva, and proficiency in MS Office Suite are also necessary. The role requires up to 20% domestic and international travel.
The anticipated salary for this position ranges from $135,000 to $150,000 annually. Kyowa Kirin North America offers a comprehensive benefits package, including a 401(k) plan with company match, annual bonus program, generous paid time off, healthcare benefits, health savings and flexible spending accounts, well-being programs, life and disability insurance, concierge services, long-term incentive programs, pet insurance, tuition assistance, and employee referral awards.
Kyowa Kirin North America is a fast-growing global specialty pharmaceutical company dedicated to discovering and delivering novel medicines in areas such as bone and mineral disorders, hematologic conditions, oncology, and rare diseases. The company emphasizes a culture of compliance, continuous improvement, and quality, providing employees with opportunities for professional growth and development within a collaborative and innovative environment.