Director, Operations

Job Description Summary

Under minimal direction, this position is responsible for managing and directing all operational activities of the laboratory, including core processes and support services, to ensure efficient, effective, and compliant operations aligned with organizational goals and objectives. The Director of Operations fosters a positive culture, and drives continuous improvement and innovation, including the transition to a fully automated laboratory environment. This position manages professional, technical, and administrative staff.

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

• Provides effective leadership to achieve high levels of service, product quality, financial results, and other criteria in accordance with policies, goals, and objectives.
• Fosters a culture of collaboration, accountability, and continuous improvement, emphasizing employee involvement, empowerment, and professional growth.
• Leads the transition to a fully automated laboratory, ensuring integration of automation with testing equipment and workflow processes.
• Develops and implements strategies to optimize automated workflows, enhance efficiency, and maintain high-quality standards.
• Hires, supervises, trains, develops, and evaluates performance of assigned personnel; manages staff development, performance improvement, investigations, and performance management.
• Leads and motivates managers, supervisors, and team members.
• Communicates new and revised enterprise policies and procedures to team members, ensuring timely and accurate implementation.
• Assists in the development and implementation of the strategic plan for the laboratory, establishing objectives and procedures governing performance.
• Ensures team members are trained and comfortable with automation systems and can troubleshoot, manage, and enhance automated processes.
• Leads organizational excellence initiatives (e.g., stakeholder meetings, kaizens, Gemba walks, process improvements, process mapping).
• Participates in enterprise-wide activities and teams to assure organizational excellence and alignment.
• Directs all laboratory operations, including sample management, donor testing, support services, and equipment maintenance.
• Ensures compliance with internal SOPs, external regulations (FDA CFR, CLIA, AABB, OSHA, Workers' Compensation), and company policies.
• Performs duties delegated to the CLIA Technical Supervisor to ensure regulatory compliance.
• Leads or participates in management team meetings, regulatory/client inspections, and internal/external audits.
• Assists in the design, planning, construction, and alteration of facilities, including project management tracking and timelines.
• Oversees laboratory equipment, including validation, maintenance, quality control, trending, and repairs.
• Assists with the implementation and maintenance of the Quality Assurance Program for the laboratory.
• Reviews statistical information, test data, quality control, incident reports, and deviations; recommends and ensures completion of corrective actions.
• Oversees the implementation of new clients, assays, equipment, and software at the local facility.
• Provides oversight of the Environmental Health and Safety (EHS) program for assigned facilities, and provides EHS program coverage as needed.
• Assists with the preparation and implementation of annual operating and capital expenditures budgets.
• Reviews ongoing cost analyses of all test services and laboratory operations to ensure operational efficiency and identify anomalies or trends in the data.
• Performs all other duties, at the discretion of management, as assigned.

REQUIRED QUALIFICATIONS  

• Education: Bachelor's Degree in a related area required
• Experience: Minimum 8 years of relevant laboratory experience, including at least 5 years in progressively responsible leadership roles
• Experience with high-volume laboratory production
• Knowledge of federal, state, and local regulations as they relate to laboratory operations
• Working knowledge of management processes (planning, budgeting, organizing, implementation)
• Must satisfy CLIA requirements for High Complexity Testing

PREFERRED QUALIFICATIONS 

• Master's degree
• Experience with laboratory automation
• MT, ASCP (or equivalent) Specialty Certification
• Trainer Certification
• Certifications as required by applicable states

SKILLS & ABILITIES

• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities
• Must be able to maintain confidentiality
• Strong technical, analytical, statistical, personal organization, and problem-solving skills
• Comfortable with laboratory automation systems and able to manage, troubleshoot, and enhance automated workflows
• Ability to work in a team environment and participate as an active member of management
• Effective oral and written business communication skills
• Ability to think strategically, synthesize complex business and financial data, and develop innovative solutions
• Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate managers and team members
• Ability to establish priorities and follow through on projects, paying close attention to detail with minimal supervision
• Proficient computer skills
• Ability to organize, prioritize, and execute a variable workload and multiple priorities

PHYSICAL & TRAVEL REQUIREMENTS

• Office and laboratory work environment
• Travel: 20-25%
• 5+ hours per shift: Sitting, standing, handling, finger dexterity, pinching
• Up to 3 hours per shift: Walking, climbing, bending, squatting, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, carrying/moving items up to 40 pounds, lifting to 40 pounds

The above statements are intended to describe the general nature and level of work performed by people assigned to this job.  They are not intended to be an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. Creative Testing Solutions is an Equal Opportunity Employer.

Additional Job Details:

Shift 1

Monday to Friday Day Shift

Creative Testing Solutions is an equal opportunity employer.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to  to let us know the nature of your request. A representative will respond to accommodation requests within two business days.  Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.

Please see the below information about applicant rights and our commitment to compliance:

EEO is the Law

EEO is the Law Supplement

Pay Transparency

e-Verify

All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines.

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