This position is responsible for operations for the business including, but not limited to, Production Planning, Logistics, Laboratory Operations, Testing, Engineering & Automation, and Equipment Maintenance.
- Direct Day-to-Day Operations of the Phoenix Production Laboratory. Manage all aspects of the Phoenix Production Laboratory including, but not limited to, Quality, Production, Clinical, Logistics, Regulatory Affairs, Laboratory Operations, Testing, Engineering & Automation, and Equipment Maintenance.
- Plan, direct, analyze, improve, and modify the work of a staff of leaders, professional, technical and clerical employeesengaged in conducting operations to meet or beat committed key client metrics, including but not limited to: turn-around-time, quality, testing results/recommendation communications, etc….
- Determine existing Operational Quality levels. Assess these quality levels against Industry Leading metrics. Utilize the DMAIC Process to drive quality improves in all areas not performing at Industry leading metrics. The Goal is Zero Defects in All Patient and Physician required Information and Analysis.
- Oversee annual budget reviews; work with the finance team to measure progress monthly and quarterly adjusting basedon forecasted and actual demand. Develop a headcount and staffing plan that supports the budget and work withfinance and HR teams to staff and train accordingly. Approve requisitions for Headcount, materials, and supplies.
- Prepare and present monthly, quarterly, and annual progress reports concerning the status of all operational areas underyour leadership.
- Manage Operational Costs and Capital expenditures in alignment with Caris Life Sciences annual budget, monthly/quarterly forecasts, and overall P&L plan. Create and support new P&L opportunities approved by the Executive Committee and the Board of Directors.
- Participate and support the long-range Capital and Technology plans, with in the Strategic Operations Plan in alignmentwith the 1, 3, & 5-year Caris Life Sciences Strategic Plan.
- Develop, Create, and Execute a Clinical Process Change Management Review Board (CMRB). This CMRB should be led by the head of Quality Assurance, and have the minimum following Reviewing/Approving Leadership – VP of R&D, VP of Operations, VP of Information Technology, with appropriate backup Leadership. All Process changes that impact clinical, testing, resources, capital, or technology must be brought to the CMRB for Review and Approval
- Support compliance to all applicable regulatory and standard requirements (CLIA, NYS, CAP, ISO, etc.).
- Collaborate with the senior management team on modifications to the test menu.
- Develop new and revises existing polices and defines Operational goals and objectives; guides staff members in establishing appropriate priorities; monthly, quarterly, and annually evaluates operational performance in relation to goals and objectives. All Operational areas should develop and execute a Continuous Quality, Key Metric, and Process Improvement plan.
- Consult with the VP of R&D, VP of Information Technology, Finance and HR teams, and other professional staff as needed.
- Work with HR regarding all leadership or colleague discipline and promotions; leave and overtime authorizations. Make sure all leaders and colleagues have a fair non-biased performance evaluation at least every 6 months
- Maintain the confidentiality of all patient information according to federal, state and local guidelines and regulations.
- Create a Development and Training plan for all leaders and colleagues, at least annually. Allow Leaders and colleagues timeto participate in career or skill development activities. Develop an Operations Succession plan, provide opportunities for leaders to take on stretch assignments, and allocate personal time to mentor and coach key leaders across Caris Life Sciences team.
- Knowledge, Skills, and Experience
- 10+ years of experience leading Operational Areas, with at least 5 + years of clinical, prescription, or laboratory operations, inclusive of, but not limited to, CLIA, NYS, CAP, & ISO regulated environments.
- Knowledge of laboratory safety and quality control Processes (DMAIC, Six Sigma, etc…) procedures and regulations.
- Ability to multi-task and work in a fast-paced, deadline driven environment.
- Proficient in Microsoft Office Suite and Internet for business use.
- Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place thatlead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
- Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
- Teamwork – Commitment to the successful achievement of team and organizational goals through a desire toparticipate with and help other members of the team.
- Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.
- Education, Certification/Licensure, and/or Experience
- B.S. degree in a scientific discipline (or equivalent work experience), with an MBA, MS, or PhD in a business related field (desirable).