Quality Assurance, Compliance Specialist

Company: Kyowa Kirin
Location: Princeton
Posted on: January 27, 2023

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:
The Specialist, Quality Assurance will play a leading role in reviewing the Regulatory Guidance to help ensure regional compliance, performing the internal audit, and contributing to the Inspection Readiness activities.
Essential Functions:
* Performs internal audits as directed, monitoring CAPAs and liaising with auditing groups and SMEs as required.
* Works with colleagues and the Global Regulatory Intelligence group to review new Guidance and incorporate it into related Kyowa Kirin quality systems.
* Maintains Internal Inspection Readiness files and helps coordinate the inspections.
* Assists with regulatory inspection readiness activities for the North America locations and subsequent responses.
* Creates procedures and training materials for related processes.
* Supports other Quality functions as necessary, i.e. Quality Systems, Quality Operations, Annual Quality Product Reviews, etc.
* Helps compile data required for communication with FDA and other regulatory agencies.
* Participate in cross-functional teams, as needed.
* Support and assist in managing the supplier module in eQMS
* Oversight and participation in the vendor evaluation process for the North America vendors.
* Act as a backup to the complaint group.
Requirements:
Education
Bachelor's Degree in a life science-related discipline is required. Advanced degree preferred
Certified auditor preferred
Experience
5+ years of GMP quality assurance experience, including quality management systems. Experience performing audits and playing a role in regulatory inspections.
In-depth knowledge of pharmaceutical industry regulatory requirements. High level of familiarity with practices needed to maintain compliance in the areas of audit programs and an ability to assess issues and develop solutions.
Technical Skills
Proficient in MS Office Suite.
Veeva VQD and/or eQMS
Experience with Audit Utopia a plus

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.
Recruitment & Staffing Agencies
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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Keywords: Kyowa Kirin, Trenton , Quality Assurance, Compliance Specialist, Other , Princeton, New Jersey