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 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 Kirins 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 organizations 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

Bachelors degree in Biotechnology or related Life Science (minimum)
Masters degree in Biotechnology or related Life Science (preferred)

Experience

With a Masters Degree:
5 years of experience in a Quality Control laboratory within GxP-regulated biopharmaceutical manufacturing operations.
With a Bachelors 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$129000 to $193500. 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.

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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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