Senior Manager, Laboratory Operations

About the role

The role:

• Recognize, exemplify and adhere to ICON's values, which focus our commitment to People, Clients and Performance.
• Create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Develop, implement and manage to performance standards for staff related to quality and efficiency, including productivity. Manage the adherence to written internal and external quality control procedures in order to ensure the quality of the results. Evaluate means and standard deviations for quality control materials and maintain Corrective action logs as appropriate.
• Build strong and effective teams, valuing different contributions; work with and through others, involving people in issues that affect them. Assist management in the recruitment and selection of staff.
• Operate independently with a willingness to make decisions; project credibility and make a professional and positive impression on others; monitor progress and hold self and others accountable. Liaise with clients, vendors and staff on all department issues.
• Identify the key elements of a situation and any gaps and inconsistencies in data. Make rational judgments from available information and analysis. Actively participate in Root cause analysis investigations and process improvement initiatives. Responsible for timely and accurate responses to Quality Issues assigned to them and/or their department.
• Create an environment that motivates people; identify development opportunities for self and others; act as a coach and mentor and share expertise. Maintain a positive working environment ensuring staff motivation in particular periods of high workloads. Contribute to the retention of key individuals.
• Assess work performance and develop supporting staff skills, encourage growth and provide regular performance feedback.
• Review daily, weekly, and monthly metrics for assigned departments and implement as necessary staffing reallocation to ensure efficiency and quality.
• Oversee work performed by all staff.
• Set priorities for the team to ensure task completion; coordinate work activities of others including scheduling to work outside of normal working hours when required.
• Evaluate performance of staff and develop supporting staff skills, encourage growth and provide regular performance feedback.
• Mentor and coach staff. Train new employees.
• Manage the recruitment, training and development of staff in the various sections of the laboratory as required. Perform continuing education of laboratory staff in the various sections of the laboratory and sample management as required.
• Responsible for the quality and timelines of technical procedures to ensure full compliance with CAP, relevant government regulations, GDP and other relevant standards as determined by the company. Monitor reagents and supplies for section and assist in the performance of all related tasks for managing inventory.
• Maintain oversight of reagent and supply orders and approval of inventory purchases together with invoice coding. Assist the Corporate procurement team and negotiate pricing and service requirements with Vendor representatives in the best interest of ICON.
• Effectively monitor laboratory operations in section and provide guidance to staff for all issues that arise including but not limited to, instrument failures, reagent/quality control issues, sample integrity issues, delays in testing and communication of abnormal results.
• Manage the evaluation of and validation of new methodologies and instrumentation works closely with Global Validations Department.
• Be aware of all pertinent employee health and safety regulations and requirements for their assigned department and manage compliance to same.
• Approve purchase orders and all appropriate purchases for department area.

Requirements

• Advanced degree (PhD, MD, DO, MSc, or BSc) in a clinical, biological, chemical, or laboratory science.
• 10+ years of progressive leadership experience in clinical or specialty laboratory operations.
• Demonstrated experience leading CAP/CLIA-accredited specialty laboratories and managing regulatory inspections.
• Proven track record of scaling lab operations and delivering financial performance.
• ASCP and NYS License required.

Core Competencies

• Laboratory leadership in clinical testing laboratory
• Regulatory experience (CAP, CLIA, global equivalents)
• P&L management and investment governance
• Change leadership, automation, and digital transformation
• Stakeholder engagement with Medical, Quality, Commercial, and Clients
• Talent development and succession planning

Benefits

• Competitive salary packages
• Health insurance offerings
• Retirement planning offerings
• Global Employee Assistance Programme
• Life assurance
• Flexible country-specific optional benefits