Associate Director/Director - Lab Operations

Job Overview

Responsible for managing laboratory staff across a large department or multiple related departments. Assists with the administration of laboratory testing in accordance with applicable regulations governing clinical laboratories. Contributes to departmental strategy and drives achievement of operational objectives for laboratory operations.

Responsibilities

• Lead and manage the daily activities of assigned laboratory work groups.
• Plan, prioritize, assign, and oversee laboratory workload and projects.
• Partner with leadership to establish performance standards and operational objectives.
• Recruit, develop, coach, and manage laboratory staff.
• Establish goals, objectives, and metrics to support operational performance.
• Identify opportunities to improve operational efficiency, quality, and financial performance.
• Participate in budget planning activities, including consumables, instrumentation, and resource requirements.
• Act as an escalation point for operational, quality, safety, and supply chain challenges.
• Ensure compliance with laboratory regulations, quality requirements, and safety standards.
• Partner with Quality Assurance and EHS teams to implement operational and compliance improvements.
• Drive CAPA closure, quality metrics, root cause investigations, and continuous improvement initiatives.
• Support the development and maintenance of laboratory policies, procedures, and quality systems.
• Oversee the implementation of new tests, equipment, technologies, and operational processes as required.
• Foster a collaborative culture that promotes teamwork, knowledge sharing, and employee engagement.

Qualifications

• Bachelor's Degree or equivalent combination of education and experience.
• Minimum 5+ years of relevant experience in laboratory operations, including more than 5 years working within a regulated environment and at least 5 years of line management experience.
• Practical knowledge of leading and managing execution processes, projects, and tactics for a large external sponsor portfolio.
• Regulatory knowledge and experience with GCLP/GxP requirements for vaccine and/or specialty laboratory clinical testing and assay lifecycle management.
• Strong technical understanding of operations and methods, including study setup and cross-functional/system dependencies.
• In-depth knowledge of clinical testing procedures and applicable laboratory testing regulations.
• Ability to work cross-functionally to establish a new laboratory facility, including equipment and assay technology transfer and qualification.
• Working knowledge of quality assurance and quality control principles and in-depth knowledge of company-specific program requirements.
• Knowledge of occupational safety and health rules and regulations.
• Good written and verbal communication skills.
• Effective supervision and coaching skills.
• Ability to assess and prioritize multiple tasks, projects, and demands.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Effective communication and presentation skills with the ability to influence stakeholders, including senior leadership.
• Holds applicable certifications and licenses as required by local regulations.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.