Lead Quality Control Planner

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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario. The Lead Planner, Quality Control will play a critical role in the start-up, and operations of the Quality Control organization within the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role will initially involve working in a greenfield environment and will transition to provide technical leadership to the QC organization throughout the GMP-ready, Tech Transfer, and facility licensure activities for the manufacturing of Phase III and early commercial products. Accountable to ensure compliance with the Quality Control and Manufacturing operations with current GxP Standards and with all applicable Global, Regional and Site procedures within Kyowa Kirin's Quality Management System. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to help foster an inclusive environment, consistently acting in alignment with the organization's values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts. This role reports to the Senior Manager, Quality Control

• Coordinate, schedule, and oversee contracted laboratory services and contracted staff.
• Lead quality-focused projects from concept through closure, collaborating with Clinical Operations, Regulatory, Manufacturing, and other cross-functional teams.
• Expertise in project planning, resource loading, scheduling, task prioritization, and dependency management and experienced in developing and maintaining project dashboards, minutes, status reports, and issue logs.
• Skilled in applying data-driven decision-making to evaluate project continuation, prioritization, acceleration, or redesign.
• Ability to establish standard methodologies, frameworks, and coach/mentor team members in project management and operational excellence practices.
• Experienced in QC capacity management across contract testing laboratories (CTLs), including prioritization of testing, constraint identification, and strategic resource coordination.
• Strong ability to manage QC communications, lead team meetings, and maintain alignment among internal and external stakeholders.
• Skill in authoring, reviewing, and approving SOPs, policies, protocols, and technical reports.
• Provide training and mentorship to QC analytical staff and oversee inventory management, sample movement, and collaboration with supply chain teams.
• Build and lead cross-functional project teams while driving collaborative solution development and execution and facilitate strong communication channels across Clinical, Regulatory, Manufacturing, and external partners (e.g., CTLs).
• Recognized for developing trusted partnerships and maintaining high alignment across diverse stakeholder groups.
• Conduct internal customer feedback sessions, process mapping, and business process analyses to drive operational improvements.
• Lead and implement CAPA initiatives and continuous improvement programs across Quality and QC functions.
• Capable of designing and implementing standard practices to elevate organizational project management and operational excellence maturity and proficient in managing and approving QC investigations, deviations, change controls, and CAPA development/implementation.
• Skilled in ensuring QC laboratory compliance, overseeing documentation integrity, and maintaining audit readiness and strong working knowledge of cGMP regulations, FDA/ICH guidelines, and Quality System requirements.
• Experienced in Quality Agreements, regulatory filings, and Health Authority engagement.
• Assist in annual Quality budget planning, partnering with Quality leadership and Finance to track, forecast, and manage departmental spending and resources.
• Competent in managing PO accruals, quotes, invoices, KPIs, and providing periodic financial and operational updates to management. Education
• Bachelor's degree in Biotechnology, or related Life Science (minimum)
• Master's degree in Biotechnology or related Life Science (preferred) Experience
• With a

Master's Degree:

5+ years of experience in a Quality Control laboratory within GxP-regulated biopharmaceutical manufacturing operations.

• With a

Bachelor's Degree:

8+ years of experience in a Quality Control laboratory within GxP-regulated biopharmaceutical manufacturing operations.

• 5+ years of progressive experience in Quality Control, Quality Systems, and GMP compliance, including leadership of complex QC operations.
• Strong background working with contract testing laboratories (CTLs) and external partners, including project oversight and relationship management.
• Practical project management experience, including planning, scheduling, resource management, risk assessment, and cross-functional coordination.
• Deep understanding of cGMP, ICH, FDA, and EU regulatory requirements and how they apply to QC laboratories and broader Quality Systems.
• Demonstrated leadership in cross-functional teams, collaborating with stakeholders across Quality, Clinical, Regulatory, Manufacturing, Supply Chain, and external testing sites.
• Proven ability to manage competing timelines with strong project and time management skills, including expert knowledge of risk management principles and risk tolerance. Technical Skills
• Proficiency with Laboratory Information Management Systems (LIMS) and experience with Laboratory Execution Systems (LES) and Electronic Laboratory Notebooks (ELN) are preferred. Experience using LabVantage LIMS is highly desirable.
• Advanced proficiency with Microsoft tools (Excel, PowerPoint, Teams, SharePoint, Project) and established project management methodologies.

Non-Technical Skills Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural 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 sharing, maintaining a 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. Initially working on a construction site and ultimately in a biotech manufacturing laboratory. Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases. During the construction and start-up phases, employees are required to wear appropriate personal protective equipment (PPE), including hard hats, safety glasses, steel-toe boots, and high-visibility vests. Once transitioned to the GMP laboratory environment, PPE will include lab coats, gloves, safety goggles, and other gear as defined by site safety protocols. While working at our onsite corporate facility, employees are required to wear appropriate business attire aligned with our standard dress code. If traveling to both sites, one would be prepared for both arrangements. 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. Requires up to 10% domestic and limited international travel. The anticipated salary for this position will be $129,000 to $193,500. 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 . 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. #LI-SH1