We have a wonderful opportunity to provide leadership, expertise, and oversight for the Bloodworks Central Seattle Laboratories (TSL) with an emphasis on customer interactions, coordinating development, and managing resources. Provide budgetary oversight of operations. Assure that TSL departmental processes and procedures and quality control activities are compliant with accreditation and regulatory standards. Participate in the Laboratory Services management team to set the vision and direction for the Laboratory Services group. Principal responsibilities include, but are not limited to:With the Vice President, Laboratories, and the CLIA Director, set direction, vision, values, and policy for the department consistent with Bloodworks’ mission.Consistently model values of Blood Center and coach for same expectation; contribute and build upon current practices and procedures in support of values, mission, and goals. Ensure that department documents, procedures, and actions comply with all laws, regulations, standards, and policies. Ensure that staff follow these requirements.Hire, develop, monitor, and retain a successful supervisor team and indirect reports to carry out department objectives.Ensure all department employees have relevant goals and that evaluation is ongoing.Ensure the department supports a balance of employee personal and business goals.Recommend and provide systems, resources, and procedures as appropriate to achieve the department’s success.Challenge and offer support to fellow managers to ensure each department is contributing to the success of the organization.Assure resources for clinical testing and clinical trial testing. Prepare justifications to obtain needed resources in concert with the VP Laboratories and Medical/CLIA Director. Oversees departmental budget(s), preparing monthly reconciliations and forecasts as requested. Lead the development of the annual budget using utilization and pricing models, and long-term planning.Prepare documentation including SBARs and financial modeling to evaluate and support the pricing of existing tests and/or services and estimates for those under development.Facilitate evaluation, development, and implementation of new processes, methodologies, instrumentation, or software that will improve efficiencies, reduce operating costs, and/or drive the department toward state-of-the-art technology.With the department management, develop and maintain the quality plan.Develop and maintain quality control programs to ensure appropriate record-keeping for validation, calibration, and maintenance. Ensure corrective action is appropriate, complete, and timely.Coordinate with Technical staff to ensure procedures accurately reflect lab processes and are compliant with accreditation and regulatory standards.Assure the proper Proficiency Testing programs are in place. Provide for timely testing and submission of results. Prepare reports for directorial review and department sign-off.Assist in the development of validation protocols and guide the technical staff in the validation of new technology and methods.Serve as primary liaison/contact person for any internal and external departmental audits or inspections.Communicate with the CLIA Director and Vice President on significant events. Collaborate with QA/RA and Communications Departments to ensure customers are current with all new and existing regulatory requirements affecting testing and/or blood products.Develop and ensure a dynamic and comprehensive customer outreach program. Provide analysis of existing and potential markets. Collaborate with Business Development staff to expand service to existing customers and gain new customers.Provide leadership in developing data handling, interfaces, and reporting functions.Participate in scientific and professional activities regionally and nationally. For Laboratory Services Division: Collaborate with the Laboratory Services leadership team to develop annual goals and objectives that are aligned with the overall organization and support the Bloodworks’ mission and values. Provide reports to upper management on projects and laboratory administration as requested.Assure appropriate accreditation for all testing in partnership with laboratory leadership and Translational Research. Perform other duties as assigned. REQUIREMENTS: EDUCATION & EXPERIENCE: Must qualify as a General Supervisor, High Complexity Testing, under CLIA personnel requirements found in Subpart M of the Code of Federal Regulations. Bachelor of Science degree in clinical laboratory science (or equivalent combination of education and experience). Education must be equivalent to a Bachelor’s Degree with a minimum of 24 semester hours of science courses that include a minimum of 6 semester hours of Chemistry, 6 semester hours of Biology, and 12 semester hours of Chemistry, Biology, or Medical Laboratory Technology in any combination.MT/MLS (ASCP) or equivalent certification. Master’s degree in health care administration or MBA preferred.Five years experience, with progressively increasing responsibilities in a CAP/Joint Commission accredited clinical laboratory environment preferred.Five years of supervisory or equivalent leadership experience is required. Specific job skills include, but are not limited to: As a CLIA Laboratory Leader, one must satisfy periodic competency assessment requirements. Demonstrated expertise in developing and supervising a quality assurance program in a laboratory performing high-complexity testing.Demonstrated expertise in managing people and departments.Business background and customer service experience are desirable.Outstanding skills in organization, communication, coaching, and mentoring for high performance and general people skills are required.Required mental activities include continuous use of interpersonal skills, teamwork, customer service, decision-making, mentoring, problem analysis, independent judgment, and/or independent action, training/supervising, and the ability to read, write, speak, and comprehend English. Required mental activities used less frequently include the use of discretion, creativity, negotiation, presentations/teaching, and the performance of basic math (all used frequently); the performance of basic computer programming (used occasionally); and selling (used rarely).Must be able to effectively prioritize activities, and to continuously re-prioritize to accommodate tight deadlines and a varying workload; must be able to work effectively under stress and to coach subordinates on their effectiveness under the same situations.Required physical activities include continuous hearing, talking, and handling. Required physical activities used less frequently include standing, walking, reaching, and repetitive motions of hands/wrists (all used frequently); stooping, sitting, bending, kneeling, feeling, and repetitive motions of feet (all used occasionally); and climbing (used rarely).The ability to lift and carry up to 10 pounds is required, as is the ability to push up to 30 pounds.Significant manual dexterity is required to operate various instruments and to perform required data entry.Functional proficiency with Microsoft Office applications is required.Ability to comply with Bloodworks’ Mandatory Vaccinations policy.Requires ability to comprehend the criticality of the testing being performed, as it relates to the blood components being prepared for transfusion, or organs being transplanted. Includes a fundamental understanding of the financial value of the testing reagents, blood components being prepared, and the necessity to follow all regulatory rules and regulations (AABB, CFR, EU, CLIA, HIPAA, and State), including FDA’s “Good Manufacturing Practices”. Required mental activities involve the continuous use of teamwork. Required mental activities used less frequently include interpersonal skills, and the ability to read, write, speak, and comprehend English (all used frequently); decision making, creativity, customer service, independent judgment and/or independent action, the performance of basic mathematics, and the performance of accurate proofreading and correct spelling (all used occasionally); and the use of discretion, presentations/teaching, problem analysis, negotiation, mentoring, the performance of basic mathematics and programming, and the performance of advanced programming (all used rarely). Required physical activities include frequent standing, walking, talking, reaching, feeling, hearing, handling, and repetitive motions of hands/wrists. Required physical activities used less frequently include stooping, sitting, bending, and repetitive motions of feet (all used occasionally); and kneeling, crawling, and climbing (all used rarely).To obtain access to some client facilities, the incumbent may be required to apply for and obtain clearance to access the client property. This clearance process may require the incumbent to undergo additional levels of screening beyond Bloodworks’ standard pre-employment screening. WORKING CONDITIONS This is a highly regulated position and is subject to meeting various regulatory agencies and accrediting body rules and regulations. These may include but are not limited to, FDA, AABB, CLIA, and CAP.Telecommuting ability is a frequent but not permanent condition of this role.Job conditions to be expected include extensive travel, substantial overtime and on-call status (frequent); heavy lifting, constant standing, extensive close work with computer screens, and sleep deprivation (occasional); and evening meetings (rare).Ability to work scheduled “on-call” for up to 12 days each month.Bloodworks is a community-supported non-profit organization. As such, from time to time incumbents can expect to work with volunteers.As a member of the Bloodworks Leadership Team, the incumbent should be prepared to work extended and/or consecutive shifts and/or possibly at a different location during periods of inclement weather or other emergencies. Ability to work scheduled holidays and weekends.This position has indirect exposure to blood-borne pathogens.Benefits and Perks:Employees regularly scheduled for 24 hours per week are covered by medical, dental, vision, and life insurance, with family coverage also available. Also, able to participate in retirement plans (401a & 401b), consolidated paid leave program (4.8 – 6.8 weeks of time off accrued per year, based on length of service), subsidized backup child care program, subsidized transit program, educational reimbursement. Candidates hired from outside of our service area may be eligible for a relocation assistance bonus**Conditions apply