Associate Director, Quality Control

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.

Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.

Our culture is grounded in our values: Commitment to Life , Integrity , Innovation , and Teamwork/Wa , and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.

We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com .

Summary of Job:

The Associate Director, Quality Control will play a critical role in designing and executing the operational readiness program for star- up of the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. The Associate Director position will lead and enable the timely completion of key milestones for ensuring production targets are achieved. This role will initially involve working in a greenfield environment and will transition to lead the Lab operations throughout the GMP-ready, Tech Transfer, Analytical Method Transfer, and facility licensure activities for the manufacturing of late clinical and commercial products. Accountable to ensure compliance of the QC laboratory areas with current GxP Standards and with all applicable Global, Regional, and Site procedures within Kyowa Kirin’s Quality Management System.

The role will serve as a primary delegate representing the Sr Director, Quality Site Head as required to ensure timely, effective, and compliant execution of operational activities per approved plans and schedules. The Associate Director, Quality Control will play a critical role in designing, developing, and executing the operational readiness program for start-up of the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC.

You will lead and enable the timely completion of key milestones to ensure production targets are achieved. This role will initially involve working in a greenfield environment and will transition to lead the Lab operations throughout the GMP-ready, Tech Transfer, and facility licensure activities for the manufacturing of Phase III and commercial products. Accountable to ensure compliance of the QC laboratory areas with current GxP Standards and with all applicable Global, Regional, and Site procedures within Kyowa Kirin’s Quality Management System.

As a people leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization’s values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to address individual and team needs effectively. You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally, you will help teams navigate through change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset.

Essential Functions:

Technical Skills, Knowledge, and Experience

Shapes functional area strategy, influences cross-functional initiatives and drives organizational improvements.

Provide technical leadership collaborating cross-functionally in the site early-stage activities, including: implementation and qualification of facility, utilities’, equipment, and analytical instruments; development and approval of user requirements review; prioritization for implementation and transfer of analytical methods required for facility start-up (GMP ready/OQ Complete); ICT efforts for developing user requirements and implementing selected electronic Quality Systems for the operations (LIMS/ELN/Empower).

Establish and maintain Quality Control procedures as applicable to the Site QMS Laboratory Controls Sub-system and develop training requirements for QC Staff.

Lead and coordinate cross-functionally a robust and compliant and timely implementation for all the required analytical, biochemical, and microbiological test methods by completion of the required steps from method development, qualification/optimization, validation, or suitability for compendial methods, and/or transfer.

Establish a Raw Materials sampling, testing, and release program in compliance with all applicable regulatory requirements (JP, USP, EP, etc.).

Develop, implement, and ensure a robust, efficient, and compliant raw materials supplier qualification program.

Coordinate testing and reporting of laboratory results in support of the facility Environmental and Utility monitoring program.

Lead the QC Lab operations to achieve all required validation and qualification activities for the facility, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.

Ensure laboratory electronic systems and records are compliant with current 21 CFR Part 11 and Data Integrity (ALCOA++) requirements.

Hire, onboard, train, and mentor QC staff per approved staffing plans.

Lead/ensure timely investigation of deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate actions (CAPA) for resolution working cross-functionally.

Establish key performance indicators for the QC laboratories (for example: OOS, Invalid Assays, OOT, Lab Deviations, Testing Turn-around-Times, EM Data trends, etc.).

Implement and manage the Contamination Control Strategy (CCS), for the site, working cross-functionally.

Assist Quality Site Head in identifying and qualifying contracted lab services and/contingent staffing as required (e.g.: Disinfectant Efficacy Studies, Mycoplasma, in vitro adventitious virus testing).

Lead the QC Lab activities required to successfully respond to regulatory requests, complete regulatory and internal inspections of the facility and laboratory areas.

Leadership

Results-Oriented: Lead teams by setting clear, measurable goals and ensuring accountability for achieving key objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within set timelines.

Empathetic Communication: Listen carefully, give helpful feedback, and handle conflicts with care.

Team Development: Mentor and guide team members, create actionable growth plans, support ongoing learning, and develop the team with a patient-focused mindset.

Inclusive Leadership: Build a diverse, respectful environment where everyone feels valued and supported.

Supportive Environment: Encourage a positive workplace, celebrate achievements, and promote work-life balance.

Collaboration: Lead by example,