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Senior Manager, GxP Inspections

Company: Kyowa Kirin
Location: Princeton
Posted on: September 21, 2022

Job Description:

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 three 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.
As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.
Summary:
* Provide Global Kyowa Kirin organizations with GxP inspection support pre, during and post Regulatory Inspections at Kyowa Kirin sites as necessary.
* Provide support through the One Kyowa Kirin concept to all Kyowa Kirin operations worldwide for compliance with the global requirements.
Essential Functions:
* Provide Global Kyowa Kirin organizations with GxP inspection support pre, during and post Regulatory Inspections at Kyowa Kirin sites as necessary.
* Provide support through the One Kyowa Kirin concept to all Kyowa Kirin operations worldwide for compliance with the global requirements.
* Collaborate effectively with colleagues across all Kyowa Kirin sites to support inspection readiness as required
* Evaluate quality issues for risk
* Contribute to the continuous improvement for Kyowa Kirin's QMS
* Maintain full awareness of global GxP requirements for global inspectorates
* To support the GxP functions, sites and the QA Leads by providing project-managed audit/s, subject matter expertise, review/s and inhouse consultancy on request.
Requirements:
Education:
Bachelor's Degree required.
Experience:
* Inspection management or Inspection project management
* Inspection readiness activities
* Excellent working knowledge of CAPA and RCA
* Broad experience of working within the pharmaceutical and/or biotechnology industry with several years' experience operating in a QA Management position
* Excellent working knowledge of international GxPs, especially in the interpretation of UK MHRA, EMA and US FDA and PMDA requirements, for the manufacture, control and distribution of commercial product, clinical trial supplies and pharmacovigilance.
Technical Skills:
Proficient in MS Office Suite
Preferred skills (not required):
* Sound knowledge of manufacturing sites
* Auditing experience
* Sound knowledge of validation techniques for sterile/aseptically-filled biologic pharmaceuticals.
* Direct Project Management and oversight experience
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 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. 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 usprivacyoffice@kyowakirin.com.
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Keywords: Kyowa Kirin, Trenton , Senior Manager, GxP Inspections, Executive , Princeton, New Jersey

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