Lab Manager, Immunoassay

Job OverviewResponsible for managing a team of laboratory staff within a large department or several related departments. Assists with administration of laboratory testing in accordance with applicable regulations governing clinical laboratories.   Contributes to establishing departmental strategy and drives achievement of objectives for annual success of lab operations.

Essential Functions• Manages and directs 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 assigns workload. Plans, prioritizes and assigns tasks and projects.• Partners with leadership to develop performance standards.• Responsible for hiring, training, performance management, and development of staff.• Contributes to departmental strategy and establishes goals and objectives for team members for achievement of operational results. Establishes relevant metrics to drive departmental success.• Identifies and drives opportunities for cost savings and driving revenue. Participates in budget planning process based on revenue targets and financial goals, inclusive of consumables, instrumentation, and resourcing needs.• Serves as an escalation point to drive resolution of challenges in operations, quality, safety, supply chain efficiencies across multiple departments.• +H36• Accountable for ensuring safety and regulatory compliance. Collaborates with QA and EHS to ensure enhancements are implemented to support operational capacity.• Acts as primary business continuity representative for area of accountability.• Drives CAPA closure and resolution, quality compliance and metrics, oversight of quality incidents and resolution, root cause analysis and improvements.• Drives a continuous improvement and quality oriented culture.• Assists in establishment and revision of laboratory policies and procedures. Maintains appropriate control and quality assurance procedures.• Keeps abreast of new technical developments. Assists with implementation of new tests, equipment, programs and/or procedures in the assigned area(s) as needed. Contributes to continuous improvement initiatives to increase quality of services and operational efficiency.• 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.• Manages staff in accordance with organization’s policies and applicable regulations.

Qualifications• Bachelor's Degree in a health science field Req• 9 years of experience in a regulated laboratory environment.• 2 years of experience leading a team.• Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one department or multiple related departments.• Strong technical understanding of operations and methods. Strong knowledge of study set up and cross functional/system dependencies.• In depth knowledge of clinical testing procedures and applicable laboratory testing regulations.• 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.• Effective communication and presentation skills to influence at various levels of the business, including senior leadership.•  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://q2labsolutions.com/careers