Senior Manager, Quality Control

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 Senior Manager, Quality Control will play a critical role in designing, developing, and executing the operational readiness program for the 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 work in a greenfield environment and will transition to lead laboratory operations throughout GMP readiness, technology transfer, and facility licensure activities supporting the manufacturing of Phase III and early commercial products. You will be accountable for ensuring compliance of the Quality Control laboratories with current GxP standards and 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 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

• Provide technical leadership, collaborating cross-functionally in the site's early-stage activities, including: facility detailed design review; facility, equipment, and analytical instrument user requirements review; prioritization for implementation of equipment, instruments, and analytical methods required for facility start-up (GMP Ready/OQ Complete); and ICT efforts for developing user requirements and procuring selected electronic Quality Systems for 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, the robust, compliant, and timely implementation of all required analytical and microbiological test methods by ensuring 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.).
• Coordinate testing and reporting of laboratory results in support of the facility Environmental Monitoring and Utility Monitoring programs.
• Lead QC laboratory 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 and ensure the timely investigation of deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate corrective and preventive actions (CAPA) for resolution, working cross-functionally.
• Establish key performance indicators for the QC laboratories (e.g., OOS, Invalid Assays, OOT, Laboratory Deviations, Testing Turnaround Times, EM Data Trends, etc.).
• Implement and manage the Contamination Control Strategy (CCS) for the site, working cross-functionally.
• Assist the Quality Site Head in identifying and qualifying contracted laboratory services and/or contingent staffing as required (Disinfectant Efficacy Studies, Mycoplasma, in vitro adventitious virus testing). Lead QC laboratory activities required to successfully respond to regulatory requests and support…