Senior Manager, Product Quality Technical Lead, Quality Operations- GMP

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:

This role includes CMO technical documentation (validation, analytical methods, stability data) review to ensure commercial and clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus will primarily be technical transfers, packing, method and shipping validations, and stability program oversight with a high emphasis on biological products. 

Essential Functions:

•    Maintain and develop regional and global, strong working relationships with internal departments and Kyowa Kirin contractors in the North America region.

•    Support the North America QA Operations Team providing GMP assessment of GMP compliance for change controls for all QA activities (technical/analytical) related to the manufacturing and testing processes carried out at third party contractors. 

•    Perform QA and GMP preparation, review and approval of quality related protocols and reports at contract manufacturers and laboratories involving biological, solid oral dose, med device and drug substance related product, which include –

o    Validation / Revalidation Activities
o    Technology Transfers
o    Analytical / Method transfers
o    Shipping / Transportation Qualification
o    Process Improvements
o    Scale Up activities
o    Stability program oversight

•    Review of Master Batch documentation and executed batch documents relating to the activities above received from contractors and liaise with contractors regarding queries. 

•    To ensure GMP/GDP compliance during technical/analytical/transportation related activities and identify quality issues, investigating, reporting and resolving such issues and support the NA regional product teams. 

•    To align and sustain strong working relationships with other key functions in CMC, Technical Operation, Supply Chain and Regulatory Affairs. 

•    To conduct and support audits of contractors as required.

•    To support technology transfer, process improvement, product characterization project teams as required. 

•    Review and approve investigations, Out of Trends, Out of Specification results, deviations and complaint investigations as required.  

•    Develop Stability program oversight plan process in the North America region, working closely with Kyowa Kirin third party contractors. 

•    Reviewing and supporting North America Annual Product Quality Reviews, Annual Reports and appropriate sections of product dossiers. 

•    Leads/Assists in the coordination of significant quality events including fact finding, investigation and recovery actions.

•    Ensure that documents and data comply with Data Integrity regulations and expectations.

•    Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement, and cross-functional team building.
                                     

Requirements:

•    Bachelor’s degree in a relevant scientific/technical discipline or equivalent experience in the pharmaceutical industry.

•    Strong knowledge and experience of Biologics and Small Molecule in pharmaceuticals including Med Device. At least 7 years of experience in the pharmaceutical industry which relates to the responsibilities as stated.

•    Strong knowledge of international cGMP/cGLP/cGDP/Med Device and health authority expectations.

•    Prior experience with Stability programs, Microbiology, and Medical Devices are preferred

•    Prior experience reviewing and approving technical, analytical qualification & validation protocols and reports and investigations is a strongly preferred skill.

•    Previous experience in one of the following quality control, quality assurance, auditing, or regulatory affairs.

•    Ability to evaluate technical and analytical information and render judgments on quality risks and regulatory compliance.

•    Strong organizational skills with the ability to participate and communicate effectively on cross-functional teams, across business unit lines and geographic regions.

•    Effective technical, verbal & written communication skills and strong overall interpersonal skills

•    Ability to communicate and manage change effectively across cross functional teams and regions where applicable.

Technical Skills:

Strong computer skills are essential, with a good working knowledge of Microsoft Office Suite as a minimum requirement. Experience with computerized QMS systems (i.e., Veeva, TrackWise etc.)

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 [email protected]. Controller’s data protection officer can be contacted at [email protected]. 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 [email protected].

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