Job Overview

Responsible for managing a team of laboratory staff. Assists with administration of laboratory testing in accordance with applicable regulations governing clinical laboratories.

RESPONSIBILITIES

• Manages the daily activities of assigned laboratory work group(s) through appropriate delegation, technical skills training, and work supervision. Meets regularly with staff and senior management to discuss and resolve workload and technical issues.
• Screens and supports the scheduling of workload assigned to the laboratory staff. Plans, prioritizes and assigns tasks and projects. Determines resourcing needs to ensure effective delivery.
• Counsels, trains and coaches laboratory staff. Assist in developing performance standards. Monitors work, develops staff skills, and evaluates performance.
• Sets week to week operational activities for the team.
• Manages staff in accordance with organization’s policies and applicable regulations.
• Provides technical leadership to lab staff and crossfunctionally in the area of expertise.
• Troubleshoots complex technical challenges and implements resolutions.
• Responsible for hiring, training, performance management, and development of staff.
• Actively participates in the development of standard operating procedures.
• Stays abreast of regulatory changes and identifies need for updates to internal procedures. Leads the revision of procedures to meet regulatory requirements.
• Responsible for harmonizing global operational processes, as applicable.
• Independently identify and evaluate instrumentation platforms.
• Evaluates cost considerations of new technologies and testing.
• Participate in budget planning process based on revenue targets and financial goals, inclusive of consumables, instrumentation, and resourcing needs. Identifies opportunities for cost savings for reagents and supplies.
• Accountable for ensuring adequate supply and inventory for testing delivery. Responsible for ensuring spend is within budget.
• Accountable for ensuring activity in the department meets quality and safety standards. Drives individual accountably for quality and safety across the team. Leads quality and safety investigations, drives resolution for enhancements.
• Participates in discussion around strategy planning for their area of expertise.
• Monitors and analyzes operational metrics to identify areas for improvement. Drives continuous improvement initiatives to increase quality of services and operational efficiency.
• Ensures timely and appropriate resolution of CAPA and quality incidents, quality and compliance metrics, root cause analysis and improvement.
• Assists in establishment and revision of laboratory policies and procedures. Maintains appropriate control and quality assurance procedures.
• Keeps abreast of new technical developments. Assist with implementation of new tests, equipment, programs and/or procedures in the assigned area(s) as needed.
• Fosters a unified culture and facilitates collaboration, cooperation, sharing of information and teamwork. Participates in initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company's procedures and applicable regulatory requirements.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's Degree Required
• 7 years of experience in a regulated laboratory environment required
• Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.

REQUIRED KNOWLEDGE, SKILLS,AND ABILITIES

• Strong understanding of operations and methods. Strong knowledge of study set up and cross functional/system dependencies.
• In depth knowledge of lab testing procedures and applicable laboratory testing regulations.
• Ability to analyze and interpret complex data.
• 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 oral 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.
• Applicable certifications and licenses as required by local regulations.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status