Listing 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 Senior Manager of Product Serialization & Security is responsible for setting the vision, strategic objectives, and roadmap for track & trace and serialization products ensuring compliance with serialization regulations. This role will own value realization for serialization products, working closely as a strategic partner with technology and business leadership team, leading efforts associated with Kyowa Kirin’s compliance with DSCSA requirements, which will include establishing and enabling standard operating procedures, supporting review of serialization details during lot release and movement of product across Kyowa Kirin’s supply chain, conducting product verification and tracing, serialized data exchange, exception handling, response to all internal and external DSCSA related inquiries, and investigations of suspect and falsified products.. This position will serve as the point of contact and Subject Matter Expert within Kyowa Kirin for these efforts.

The Senior Manager of Product Serialization & Security is also responsible for supporting efforts to identify and mitigate risks associated with the distribution of Kyowa Kirin products in North America (including US and Canada) with emphasis on commercial packaging components and outbound distribution to customers & patients, additionally supporting suspect product investigation, regulatory reporting requirements and coordination of investigations with supply chain partners.

This role will require the ability to work across multi-functional and diverse teams including stakeholders both internally within Kyowa Kirin North America and Global as well as lead the strategy and innovations for internal & external manufacturing & supply developing architecture and driving the technology roadmap with partners and Serialization software service provider(s).

Essential Functions:

• Develop and implement DSCSA policies, procedures, and guidelines, understand concurrent industry trends and solutions, and benchmark process and practices to meet business needs and regulatory compliance obligations.


• Provide oversight of Kyowa Kirin’s EPCIS data exchange, customer verification requests, error identification and resolution, and provide inputs as subject matter expert on master data changes through product lifecycle management.


• Lead / support efforts relative to Kyowa Kirin’s efforts to advance supply chain security measures.


• Develops, tracks, monitors and seeks to improve metrics supporting Kyowa Kirin’s DSCSA compliance and Product Security initiatives.


• Support the review and approval process for labeling artwork, ensuring serialization requirements are adequately accounted for in pack revision and new product introduction.


• Interact with and support integration of serialization processes with ERP systems, master data and supply chain processes.


• Monitor developing regulation via FDA and other regulatory bodies focusing on the product portfolio within KKNA’s remit to ensure compliance to current requirements and proactively develop solutions to meet future change requirements, while maintaining validated status of serialization processes.


• Perform various other duties as assigned.
  

   

  
  Job Requirements:


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  Education

  
  
  
  
  • BA or BS degree in business, supply chain management, computer science or equivalent
  
  
  
  

  Experience

  
  
  
  
  • At least 7 years total business experience: pharmaceutical, serialization, IT / data, supply chain, order to cash
  
  
  • Experience in Dynamics 365, VerifyBrands, Tracelink or equivalent ERP / serialization solution.
  
  
  
  

  Technical Skills

  
  
  
  
  • Proficient in diagnosing & evaluating EPCIS / XML data and adoption of GS1 standards
  
  
  
  

  Non-Technical Skills

  
  
  
  
  • Business acumen
  
  
  • Excellent analytical and problem solving skills
  
  
  • Presentation skills
  
  
  
  

 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.