Product Quality Associate

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 disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

The Product Quality Specialist is responsible for reviewing CMO batch documentation to ensure that commercial and clinical supplies comply with current Good Manufacturing Practices (cGMP) regulations and relevant regulatory submission requirements. Key areas of focus include packaging, labeling, and distribution activities, ensuring they meet industry standards and regulatory expectations. This role reports to the Manager, Quality Assurance Batch Disposition.

Key Responsibilities:
Evaluation and disposition of commercial and clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our company and compliance with all governing regulations.
* Review production and packaging records, shipping temperature data loggers, Certificates of Analysis (COA), and Certificates of Compliance (COC), and authorize product distribution within the North America region.
* Review and approve investigations, Out of Specification (OOS) results, deviations, and complaints as necessary. Identify, communicate, and escalate potential issues to management as appropriate.
* Ensure that documents and data meet regulatory Data Integrity standards and expectations.
* Ensure adherence to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for the manufacture, release, and distribution of commercial and clinical medicinal products.
* Coordinate and/or support the preparation and review of procedures, processes, and quality improvement initiatives. This includes reviewing and dispositioning procedures for intermediate products, finished products, labeling, and packaging records related to biologic and/or small molecule products.
* Collaborate across various functional areas and business teams to ensure robust processing, continuous improvement, and team building across the organization.
* Lead and complete projects aimed at improving process performance, including continuous process improvements, investigations, Corrective and Preventative Actions (CAPAs), and value capture initiatives to enhance outcomes, reduce costs, and optimize processing cycle
* Develop and maintain relationships with Contract Manufacturing Organizations (CMOs), Kyowa Kirin facilities, and affiliates involved in manufacturing and distribution.
Establish, update, and monitor compliance with Quality Technical Agreements (QTAs).

Job Requirements:

Education
Bachelor's degree in science, engineering, or closely related discipline.

Experience
* Minimum of one year of product quality specialist role within the pharmaceutical industry preferred
* Knowledge and experience of Biologics and Small Molecule pharmaceutical industry preferred
* Understanding of international cGMP and health authority expectations preferred
* Experience in batch disposition (release) activities for both commercial and clinical records is highly preferred.
* Proficient in reviewing and approving investigations, managing deviations, and supporting Corrective/Preventive Actions (CAPAs) preferred
* Ability to evaluate technical information, assess quality risks, and ensure regulatory compliance.
* Knowledge of Good Distribution Practice (GDP) experience is a plus

Technical Skills
* Proficient in MS Office Suite.
* Experience with computerized QMS systems (i.e. Veeva, Trackwise etc.).
* Strong written, verbal, and presentation skills
* Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.

Non-Technical Skills
* Highly motivated and great attention to detail.
* Strong endurance to work under tight timelines and complex/changing situations.
* Excellent problem-solving skills.
* Broad level of interpersonal skills and flexibility.
* Cultural sensitivity and ability to develop consensus within a multinational organization.

Physical Demands and Working Conditions

• Normal office environment with prolonged sitting and extensive computer work
• Requires up to 15% domestic and international travel

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 510 Carnegie Center Dr. Princeton, NJ 08540 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.

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.