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 QA Global 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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center, Suite 600, Princeton, New Jersey 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

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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