Senior Manager, Quality Control

Senior Manager, Quality Control

Sanford, NC

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.

Summary of Job:

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.

Essential Functions:

Technical Skills, Knowledge, and Experience

• 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 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 established timelines.

• Empathetic Communication: Listen carefully, provide constructive feedback, and handle conflicts with care.

• Team Development: Mentor and guide team members, create 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, promote teamwork and respect, and ensure your actions reflect the organization's values.

• Emotional Intelligence: Manage emotions thoughtfully, make empathetic decisions with a patient-focused mindset, and remain calm under pressure.

• Change Management: Help teams navigate change with clear communication and flexibility.

• Situational Leadership: Adapt your leadership style to meet the needs of the team, offering guidance or independence as needed while keeping patient outcomes in mind.

• Stakeholder Management and Alignment Building: Work with diverse stakeholders to build alignment, guide discussions toward common goals, and ensure decisions are made with a patient-focused mindset.

Education:

• Bachelor's degree in a life science or related field (minimum).

• Master's degree in a life science or related field (preferred).

Experience:

• Five (5) or more years of management experience leading GMP biopharmaceutical Quality Control laboratories and associated support areas, including QC Sample Management, Microbiology, Raw Materials, Chemistry/Biochemistry, Stability, Bioassay, and/or Virology.

• Experience supporting the start-up and operation of a biopharmaceutical manufacturing facility is preferred.

Technical Skills:

• Proficient in Empower, LIMS, ELN, LES, Microsoft Office Suite, Lean Lab practices, and Agile 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 resilience, guiding teams through evolving challenges. Demonstrate strong organizational skills, attention to detail, and a solid work ethic while exhibiting cultural sensitivity and fostering alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive and engaging interactions, and building relationships with empathy and respect. Embrace continuous learning and knowledge sharing while 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. Be resourceful and proactive by challenging the status quo, driving innovation, and developing creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

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 equipment as defined by site safety protocols.

While working at our onsite corporate facility, employees are required to wear appropriate business attire in accordance with the company's standard dress code.

If traveling between both sites, employees should be prepared to comply with the PPE and dress code requirements applicable to each location.

Reasonable accommodations will be provided as required by law.

This position is based onsite in Sanford, NC. Standard company policies regarding flexible work arrangements do not apply to this role. This is not a hybrid or remote position.

May require up to 10% domestic and limited international travel.

Compensation & Benefits:

The anticipated annual salary for this position is $137,300 to $185,000. The actual salary offered at the commencement of employment may vary based on several factors, including, but not limited to, relevant experience, skill set, qualifications