Quality Assurance, Compliance Specialist
Company: Kyowa Kirin
Posted on: January 27, 2023
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.
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.
* 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
* Supports other Quality functions as necessary, i.e. Quality
Systems, Quality Operations, Annual Quality Product Reviews,
* Helps compile data required for communication with FDA and other
* 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.
Bachelor's Degree in a life science-related discipline is required.
Advanced degree preferred
Certified auditor preferred
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.
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
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
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
email@example.com. Controller's data
protection officer can be contacted at
firstname.lastname@example.org. 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
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
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
Keywords: Kyowa Kirin, Trenton , Quality Assurance, Compliance Specialist, Other , Princeton, New Jersey
Didn't find what you're looking for? Search again!