Quality Engineer, Lead (QS&C)

Kyowa Kirin is a Japanese-based company with 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.  Our collective goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, from drug discovery to product development and commercialization.  The Sanford site is the first production facility in North America, and we are headquartered in Princeton, NJ, with offices in California and Mississauga, Ontario.  Summary of Job: The Quality Engineer Lead is a key individual contributor role with functional Quality authority leading and ensuring quality and compliance during the startup and operation of Kyowa Kirin’s Sanford, NC Greenfield site. For this role, the Quality Engineer Lead will support quality oversite to the following areas: Facilities, Utilities, Maintenance, and Equipment otherwise referred to as FUME, including associated instruments and asset lifecycle systems. This role is responsible for building, implementing, and sustaining Quality Engineering processes that enable GMP operations and long-term regulatory compliance, inspection readiness, and audit defense including interactions with health authorities while ensuring compliant implementation and risk acceptance across FUME and Drug Substance manufacturing processes.  This role independently prepares, presents, and defends Quality Engineering approaches and evidence during regulatory inspections, internal audits, and external audits.  As an individual contributor, you will take a compassionate and people-focused approach to your work while collaborating with other functional groups, both internal and external, to create a supportive and inclusive environment that align with the organization’s values. Strong interpersonal skills, acknowledging diverse viewpoints, and building cross functional relationships will be the key driver to make decisions that meet both individual and team needs. Key drivers for this role require accountability/ownership for delivering results and completing tasks, adapting to challenges while taking the initiative to problem solve with opportunities to grow, helping achieve business goals and keeping the patient first.  Reporting Relationship: This position reports to the Sr. Manager, Quality Systems & Compliance.  Essential Functions: Technical Skills, Knowledge, and Experience  • Act as the Quality Engineering lead for the Sanford site, owning priorities and outcomes and establish clear standards, work...