Director Quality Control

Salary Range: $ To $ Annually

The Director, Quality Control provides strategic and operational leadership for the Quality Control organization supporting analytical testing, microbiology, sterility assurance, environmental monitoring, laboratory operations, and product release activities across clinical and future commercial radiopharmaceutical manufacturing.

This leader is responsible for building and continuously evolving a high-performing, inspection-ready Quality Control organization capable of supporting rapid organizational growth, technology transfers, process validation, commercial manufacturing, and a nationally distributed manufacturing network. The Director establishes scalable laboratory systems, develops exceptional talent, and creates a culture of quality, accountability, operational excellence, and continuous improvement.

As a key member of the Site Leadership Team and Quality Leadership Team, the Director partners closely with LABS (R&D), Manufacturing, MSAT, Engineering, Supply Chain, and Quality Assurance to ensure compliant, efficient, and reliable laboratory operations that enable safe, timely delivery of life-changing therapies to patients.

The successful candidate demonstrates the ability to develop long-term laboratory strategy, coach and develop leaders, driving operational performance, and remain actively engaged in solving complex technical and organizational challenges within a fast-paced, high-growth environment.

Quality Control Strategy and Leadership

• Develop and execute the Quality Control strategy aligned with business objectives, growth plans, and operational excellence.
• Establish organizational structure, succession planning, workforce planning, and talent development strategies.
• Develop and manage departmental budgets, capital planning, resource allocation, and staffing strategies.
• Establish departmental OKRs, goals, KPIs, and laboratory performance and quality metrics to drive accountability, operational performance, and continuous improvement.
• Develop long-term laboratory expansion strategies that support the future manufacturing network and business growth.
• Hold leaders and employees accountable for maintaining a safe, compliant, highly organized, and professional laboratory environment.
• Partner with Quality Assurance, Manufacturing, LABS (R&D), MSAT, Engineering, and other functional leaders to align Quality Control priorities with operational, client, and business objectives.

Technical Leadership and Guidance

• Serve as the site's Quality Control technical expert.
• Provide scientific leadership and technical decision-making across analytical chemistry, microbiology, sterility assurance, and environmental monitoring.
• Provide technical guidance and Quality Control oversight for analytical method qualification, transfer, validation, verification, and lifecycle management, while partnering with LABS (R&D) on analytical method development activities.
• Lead technical investigations involving analytical methods, laboratory systems, instrumentation, data integrity, and product quality.
• Assess Quality Control testing strategies, analytical readiness, and laboratory requirements for new customer programs, technology transfers, process validation, and commercial readiness.
• Identify and drive implementation of new analytical technologies, laboratory automation, and digital solutions that improve laboratory capability, efficiency, data integrity, and operational performance.

Laboratory Operations & Execution

• Provide strategic and operational oversight for Analytical Chemistry, Microbiology, Sterility Assurance, Environmental Monitoring, and laboratory support functions.
• Provide oversight of microbiology and sterility assurance laboratories.
• Ensure timely laboratory testing and product release activities.
• Ensure timely testing and release activities supporting client commitments.
• Oversee laboratory scheduling, capacity planning, workflow optimization, and resource utilization.
• Oversee laboratory scheduling and capacity planning.
• Optimize laboratory workflows.
• Ensure laboratory equipment, instrumentation, computerized systems, and facilities remain qualified, calibrated, maintained, and inspection ready.
• Ensure laboratory equipment qualification, calibration, and maintenance.
• Utilize performance metrics and data analytics to optimize throughput, quality, efficiency, and customer service.

Compliance, Inspection Readiness & Quality Systems

• Ensure Quality Control laboratory operations comply with applicable GMP requirements, including FDA 21 CFR Parts 210, 211, and 212, USP, ICH, data integrity requirements, and applicable international regulatory expectations.
• Maintain inspection-ready laboratory operations.
• Lead laboratory activities during regulatory inspections, customer audits, and third-party assessments.
• Lead regulatory inspections involving QC.
• Maintain a continuous state of inspection readiness.
• Provide leadership and oversight for laboratory deviations, OOS/OOT events,…