Sr. Manager, Global Change Control

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 Global Change Control Lead will manage the Global Change Control eQMS System.  Establish and maintain a compliant and effective Quality Management System governance structure for Global Change Controls in compliance with Kyowa-Kirin requirements. The individual will support the quality culture focused on continuous improvement and will be responsible for maintaining business processes and infrastructure relating to Global Change Controls that is efficient, scalable and robust to support One Kyowa Quality Systems in a global environment.   

Essential Functions:

The focus for this role will be on continuous improvement on current processes, eliminating redundancies, improving information flow and integration to increase productivity, transparency and quality amongst the global network of users. The position is responsible for contributing knowledge, leading discussions (monthly, ad hoc, quarterly) performing analysis, developing solutions, assisting with project implementation, providing training, and measuring results. 
The incumbent will define and track operational metrics and goals and hold teams accountable for completion. Other Functions include, but are not limited to:

•    Manage the electronic quality management system for Global Change Control eQMS end to end process  
•    Act as Business Process Owner (BPO) for Global Change Control System
o    Own and maintain the electronic platform for Change Control, simplifying / improving GxP compliance
o    Continued training and change support, leadership of respective Business Process Leads (BPL)
o    Work actively with other system application BPOs to ensure that system and quality goals remain aligned
o    Support system upgrades (scheduled and unscheduled)
o    Discuss configuration needs, lead the design of procedural elements such as approval matrices, notifications / escalation matrices, required training, etc.
o    Act as a Change Ambassador, assisting BPLs to lead and communicate change in their areas

Requirements:

Education:
•    BS degree required, advanced degree in a scientific field preferred. 
•    Course Training/Certification in Veeva Vault Quality Management System with additional Knowledge of computerized systems a plus.
•    Extensive knowledge of global GxP compliance regulations including US, APAC, EU, and Japan. 

Experience:
•    Minimum of 7 years’ experience in pharmaceutical or bio-pharmaceutical field with at least 5 years of experience in global quality systems.
•    Able to demonstrate knowledge of QA Change Control system principles, concepts, industry practices, and standards with the ability to evaluate processes and drive value added enhancements
•    Ability to analyze, and interpret standards, procedures, or governmental regulations/guidance.
•    Interacts with Subject Matter Experts, such as Functional Area Heads as well as end users 
•    Must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment with limited direction. 
•    Adaptable to a fast paced, complex, and ever-changing global business environment
•    Cultural sensitivity and ability to develop consensus within a multinational organization.
•    Excellent leadership skills with the ability to motivate others in a positive manner to ensure adherence to company quality standards
•    Strong knowledge of GMP, SOPs and Quality System processes. 

Technical Skills: 
Proficient in Proficient in MS Office Suite i.e., MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems. 

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.

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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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