Associate Director, Quality Control

Kyowa Kirin • Sanford, NJ

1d • Onsite

About The Position

The Associate Director, Quality Control will play a critical role in designing 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. 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. 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.

Requirements

• Bachelor’s degree in life sciences (minimum).
• 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.
• Demonstrated experience in leading/developing technical teams.
• Proficient in Empower, LIMS|ELN|LES, MS Office Suite, Lean Labs, or Agile lean.
• 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.

Nice To Haves

• Master’s degree in life science (preferred).
• Experience with starting up and operating a biopharma manufacturing facility is a plus.

Responsibilities

• 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.
• 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.
• Listen carefully, give helpful feedback, and handle conflicts with care.
• Mentor and guide team members, create actionable growth plans, support ongoing learning, and develop the team with a patient-focused mindset.
• Build a diverse, respectful environment where everyone feels valued and supported.
• Encourage a positive workplace, celebrate achievements, and promote work-life balance.
• Lead by example, promote teamwork and respect, and ensure your actions reflect the organization’s values.
• Manage emotions thoughtfully, make empathetic decisions with a patient-focused mindset, and stay calm under pressure.
• Help teams navigate change with clear communication and flexibility.
• Adapt your leadership style to meet the needs of the team, offering guidance or independence as needed, while keeping patient outcomes in mind.
• Work with different people to build alignment, guide discussions toward common goals, and ensure decisions are aligned with a patient-focused mindset.
• Lead QC Planner, QC Microbiology, QC Analytical, and QC Bioassay Laboratory Specialists, with potential for additional positions based on business needs.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager