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, 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 stay 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 different people to build alignment, guide discussions toward common goals, and ensure decisions are aligned with a patient-focused mindset.

Subordinates: Lead QC Planner, QC Microbiology, QC Analytical, and QC Bioassay Laboratory Specialists, with potential for additional positions based on business needs.

Job Requirements:

Education

• Bachelor’s degree in life sciences (minimum).
• Master’s degree in life science (preferred).

Experience

• At least 10 years of management experience leading GMP Bio-Pharmaceutical Quality Control laboratories and support areas, such as: QC Sample Management, Microbiology, Raw Materials, Analytical, Biochemistry, Stability, Bioassay, and/or Virology.
• Experience managing Quality Assurance teams within Biopharmaceutical manufacturing operations.
• Experience with starting up and operating a biopharma manufacturing facility is a plus.
• Demonstrated experience in leading/developing technical teams.

Technical Skills

Proficient in Empower, LIMS|ELN|LES, MS Office Suite, Lean Labs, or Agile lean.

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.

Physical Demands: Initially working on a construction site and in a biotech manufacturing site in Sanford, NC. Work is 100% on-site. This is not a hybrid or remote role.

Working Conditions: Requires up to 10% of domestic and limited international travel.

The anticipated salary for this position will be $156,900 to $205,900.  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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