Senior Auditor, Gcp/Glp Qa, Global Audit, Inspections And R&D Quality

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary: **Our Hybrid work model requires two (2) office visits per week OR eight (8) office visits per month, so local candidates preferred**

The Senior Auditor, GCP/GLP QAGlobal Audit, Inspections and R&D Quality is responsible for managing and conducting internal and external audits and reviews and reporting according to Kyowa Kirin standards. The Senior Auditor will support the QA program to ensure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The Senior Auditor will collaborate and provide key quality input to Kyowa Kirin's R&D function.

Essential Functions:

   Performs, reports assigned GCP/GLP audits of KK studies, including but not limited to clinical investigator sites, vendor/CROs, internal system/processes, clinical data and documents, as applicable.
   Provides input to the annual risk-based audit plan, schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
   Prepares timely well-written reports, obtains/evaluates audit responses and oversees tracking mechanism for QA audits and manages CAPA as per KK standards.
   Provides ongoing feedback to management on potential quality-related risks.
   Supports process improvement initiatives and maintenance of SOPs and other controlled documents in the quality document management systems.
   Maintains high degree of knowledge of global industry expectations and GCP/GLP regulations to ensure high quality of audits performed.
   Participates in Health Authority inspection activities for domestic and international projects (as applicable).
   Develops and delivers GCP-related training to KK staff as needed.

Requirements:

Education
Bachelor's degree required and in science/life sciences preferred.

Experience
Minimum two (2) years of experience in GCP/GLP auditing including detailed knowledge of EMA, FDA, MHRA, ICH regulations and other applicable regulatory requirements.

Technical Skills
Proficiency in MS Office Suite is critical for this role.
Use of Veeva or similar QMS systems for electronic QA Management preferred.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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