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. 

Education 
•    Bachelor’s degree in engineering or science related field required. 
•    Master’s degree in engineering or science related field considered a plus. 

Experience
•    Minimum 8 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering; including demonstrated experience serving as a Quality SME during regulatory inspections and/or audits.
•    Demonstrated experience in qualification, validation, change control, and Quality Engineering activities. 
•    Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred
•    Familiarity with DS single-use biologics operations or greenfield startup environments is preferred.

Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.

This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
This role may require travel up to 5% domestic and typically limited international travel.

The anticipated salary for this position will be $129,000 to $177,300.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• →401K with company matching
• →Annual Bonus Program (Sales Bonus for Sales Jobs)
• →Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• →Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• →HSA & FSA Programs
• →Well-Being and Work/Life Programs
• →Long-Term Incentive Program (subject to job level and performance)
• →Life & Disability Insurance
• →Concierge Service
• →Pet Insurance
• →Tuition Assistance
• →Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

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