Director, Clinical Laboratories

San Diego Blood Bank • San Diego, CA

2d • Onsite

About The Position

The Director, Clinical Laboratories reports to the Chief Medical Officer /CLIA Laboratory Director and is responsible for facilitating the design and implementation of the delivery of laboratory services, developing and recommending strategies to improve services and clinical outcomes, reaching established goals, maintaining satisfactory outcomes and contributing to the business plans and financial goals of the organization.

Requirements

• Education: California Clinical Laboratory Scientist (CLS), M.D., Ph.D., or M.D./Ph.D. (doctoral-degree scientist). Advanced degree (master's or doctoral) in relevant scientific discipline preferred for CLS-licensed candidates.
• Certifications/Licenses: Current Clinical Laboratory Scientist (CLS) license issued by the California Department of Public Health, Laboratory Field Services (required for non-physician candidates). Board certification in Anatomic Pathololgy, Clinical Pathology or combined Anatomic/Clinical Pathology (required for M.D. and M.D./Ph.D. candidates) Current State of California Physician and Surgeon license (required for M.D. and M.D./Ph.D. candidates)
• Experience: Eight (8) years of progressively responsible and demonstrated experience in high level management at a reference or health system laboratory preferred. Experience should include participation in U.S. Food and Drug Administration (FDA), State, Federal, and accrediting agency inspections, knowledge of regulatory accreditation and licensing requirements, and application of quality assurance principles. Additional experience in transfusion medicine, blood bank services, cellular therapy services, umbilical cord blood banking, molecular testing, therapeutic apheresis service and/or translational or clinical research preferred. Background in laboratory developed molecular diagnostics, and/or next generation sequencing are particularly sought. Experience serving as laboratory director, general supervisor, technical supervisor, clinical consultant, and/or technical consultant preferred.
• Skills : Knowledge of operational characteristics, services and activities of a quality program and in principles and practices used in healthcare/laboratory management, governmental compliance, internal audits, risk management, or regulatory affairs. Demonstrated abilities required to develop policies and procedures and manage budgets. Strong understanding of laboratory operations. Ability to approach challenges with confidence. Ability to perform tasks per Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations, including following detailed standard operating procedures, maintaining training, deviation reporting and good documentation practices. Strong attention to detail, precision and commitment to accuracy. Ability to organize activities effectively, use effective problem-solving techniques, and make sound decisions. Ability to communicate effectively and collaborate with internal and external customers. Good organizational and time management skills; must be able to establish priorities and multi-task. Excellent interpersonal and communication skills with a desire to forge strong professional relationships with laboratory staff and executive leadership team. Demonstrated record of academic achievement through independent or collaborative research and scholarly publications. Demonstrated commitment to diversity, equity, inclusion, and staff success. Proficient in Microsoft Suite applications (Excel, Word, PowerPoint). California Clinical Laboratory Scientist License (CLS) or California Clinical lmmunohematologist Scientist License (CIS).

Nice To Haves

• Specialist in Blood Banking (SBB) or equivalent, preferred.

Responsibilities

• Provide administrative and technical oversight of San Diego Blood Bank's clinical laboratories, including the Quality Control Laboratory, the lmmunohematology Reference Laboratory, and the Molecular Laboratory.
• Create, perform review, and approve standard operating procedures, processes, test methods, equipment validations, and other regulated documents.
• Ensure enrollment and participation in proficiency testing programs, review all results, investigate any unsatisfactory results, and implement corrective actions.
• Acquire a high degree of familiarity with technical laboratory tasks (bench work) and be able to provide supervision, assistance, and personally perform hands-on bench work when limited staffing situations arise or workflow deems necessary.
• Ensure annual competency assessment and ongoing training of all laboratory staff.
• Assist department in preparing for external inspections.
• Coordinate quality assurance and compliance-related activities with management and front-line staff.
• Assist with new/renewal applications/submissions for AABB and CAP accreditation, California State biologics and laboratory licensure, CLIA certification (accreditation and waiver), FDA registration, as well as FDA license amendments.
• Perform final review of deviations as needed.
• Participate in innovative diagnostic test development.
• Participate in corrective and preventive action teams, assist with investigation and root cause analysis, and verify that actions are implemented and effective.
• Analyze data, identify trends, and report findings to management.
• Conduct annual review of the laboratory quality plan, quality indicators, and process improvement initiatives in alignment with applicable laws, regulations and standards.
• Participate in appropriate departmental meetings, and attend other meetings as assigned.
• Enhance professional growth and development through participation in educational programs, current literature review, in-service meetings, and workshops.
• Participate in regulatory/accrediting agency inspections.
• Participate in clinical laboratory on-call responsibilities
• Participate on appropriate San Diego Blood Bank committees to facilitate communication of service needs, appropriate utilization management, and performance improvement efforts.
• Participate in laboratory emergency preparedness and disaster recovery planning.
• Aid in the development of informational/marketing materials.
• Present medical/scientific/educational information to San Diego Blood Bank clients and staff.
• Lead and/or assist in scientific manuscript and abstract preparation.
• Maintain confidentiality of sensitive information concerning patients, employees, clients, vendors, and San Diego Blood Bank.
• Contribute to the execution and reporting of relevant contract research projects.
• Take a leading role in identifying and assessing additional opportunities for growth, including the negotiation of potential strategic alliances and/or product development.
• Remain current on trends in laboratory medicine through continuing education, stakeholder and industry relations, and conferences.
• Maintain knowledge of clinical professional standards of care and scope of practice for laboratory medicine including laboratory professionals.
• Ensure laboratory staff are apprised of and aligned with San Diego Blood Bank's mission, vision, and strategic goals.
• Ensure appropriate laboratory management staff collaborate with operational staff regarding decisions on matters relating to technical performance, compliance, quality, and finances.
• Serve as a mentor to laboratory staff.
• Support continuing education for laboratory staff and/or local/regional medical community, as needed or requested.
• Fulfill the responsibilities of general supervisor, technical supervisor, clinical consultant, technical consultant, and/or technical supervisor, as delegated by the CLIA Laboratory Director, and as defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
• Provide leadership and ensure compliance with all applicable state and federal laws and regulations and with the standards of accrediting/certifying agencies.
• Embody and promote an overall culture of compliance that encourages ethical conduct and a commitment to compliance with laws, regulations and standards.
• Perform other related duties as assigned or requested.

Benefits

• Employees working 30 or more hours per week are eligible for employer sponsored health benefits (Medical, Dental, & Vision plans)
• Earn up to 120 hours of paid vacation in your first year.
• 7 paid Holidays + 1 personal holiday provided annually.
• 40 hours of paid sick time provided annually.
• 403(b) retirement plan with 3% employer match starting on your first day.
• Employee Assistance Program - Free for employees and their families
• Service Awards and recognition.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees