Quality Engineer, Lead (QS&C)

Kyowa KirinisaJapanese-based company witha fast-growing global specialty pharmaceutical company that appliesstate-of-the-artbiotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare is to translate science into smiles by delivering therapies where no adequate treatments currently existfrom drug discovery to product development and Sanford site is the firstproductionfacility in NorthAmericaandwe are headquartered in Princeton NJ with offices in Californiaand 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 Kirins 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 workwhilecollaboratingwith otherfunctional groupsboth internaland externalto create a supportive and inclusive environmentthatalignwith the organizations interpersonal skillsacknowledgingdiverseviewpointsandbuildingcross functionalrelationshipswill be thekey drivertomake decisions that meet both individual and team drivers for this rolerequireaccountability/ownershipfor delivering resultsand completing tasks adapting to challengeswhiletaking the initiativeto problem solvewith opportunities to growhelping achieve business goalsandkeepingthe patientfirst.

Reporting Relationship:

This position reports to the Sr. Manager QualitySystems& Compliance.

Essential Functions :

Technical Skills Knowledge and Experience
Act as the Quality Engineering lead for the Sanford site owning priorities and outcomes andestablishclear standards workflows and governance to ensure consistency and sustainability as the site grows.
Lead and provide Quality oversight of GMP readiness activities for facility startup including equipment utilities facilities and process validation and documentation generation.
Sustain compliance through lifecycle management of FUME systems continuous improvement and ongoing inspection readiness; confirm readiness of systems by reviewing evidence such as drawings P&IDs validation deliverables and turnover packages to ensure fitness for intended use.
Drive structured problem solving for issues related to equipment utilities facilities instruments PMs and calibrations and contribute to the creation of the Preventative Maintenance (PM) and calibration programs including review of plans intervals and criticality assessments.
Execute and/or provide quality technical leadershipofchange controls and risk assessments (e.g. FMEA hazard analysis) including defining risk strategy ensuringappropriate mitigation and approving risk acceptance decisions of FUME systems.
Drive structure problem-solving for issues related to equipment utilities facilities calibrations and PMs and ensure all activities are consistent with data integrity expectations Part 11 requirements and ALCOA principles.
Partner with Engineering Validation and Maintenance Teams tomaintaininspection-ready documentation and asset status and work collaboratively across teams to support startup activities and ensure compliant execution.
Review and approve work orders CQV protocols and reports change controls deviations and CAPAs associated with FUME systems and serve as the Quality lead for FUME related internal external and regulatory audits including inspection preparation execution and follow-up.

Non-Technical Skills
Results-oriented and able to navigate ambiguity. Demonstrates the ability to set clear outcomes track progress follow through on commitments and ensure your actions lead to measurable results that advance organizationalobjectives. Responds promptly takes accountability and manages tasks efficiently. Adapts to change with clarity patience and understanding while influencing peers and key stakeholders through evolving this role you willexhibitstrong organizational skills attention to detail and a solid work ethic whiledemonstratingcultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others perspectives fostering productive engaging interactions and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharingmaintaininga growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect integrity and humility prioritizing collective success over individual gain. Resourceful and proactive challenge the status quo drive innovation and develop creative solutions. Apply an enterprise-wide holistic mindset working beyond siloed thinking to deliver cohesive integrated solutions.

Individual contributor with responsibility to lead cross-functional project teams and provide Quality governance and influence decision making across FUME related initiatives.

Job Requirements:

Education
Bachelors degree in engineeringor science related fieldrequired.
Masters 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 $129000 to $177300. 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 Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers 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.

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Recruitment & Staffing Agencies

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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Required Experience:

IC