About the position
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.
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.
- 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).
Requirements
- Bachelor's degree in science, engineering, or closely related discipline.
- 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.
Nice-to-haves
- 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.
