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Senior Manager, Pre-Analytical

Apply Share Job ID 1384 Category Laboratory Operations Job Location Redwood City, California Posted Date 12/10/2019


The Associate Director, Pre-Analytical Laboratory Services will oversee the operations of Genomic Health's Accessioning department to ensure scalability and consistent quality of pre-analytical laboratory operations. This individual will ensure the pre and post-analytical order and sample processing systems are functioning properly and consistently achieving turnaround time targets, accessioning personnel conducts all quality-related activities as specified in the Quality Management System, and the department meets regulatory compliance and service quality. The Associate Director will lead the Accessioning department and cross-functional teams through projects and improvement activities that contribute directly to Genomic Health's key results, ensuring budgets, project schedules, and business requirements are met.
The Associate Director, Pre-Analytical Laboratory Services will provide leadership to the Accessioning team, continue to foster and facilitate the professional growth and development of laboratory support staff, and ensure that staff has the required technical skills, knowledge, capacity and passion for providing superb service to our customers. He or she will ensure staff engagement through active management, team building, and effective communication to create a culture of accountability.
The successful candidate will partner with Histology, Analytical Laboratory, Pathology, Quality, Information Technology, Process and Service Engineering, US and International Customer Services, and others to continually improve quality and service and achieve performance targets. The Associate Director will also participate in cross-functional teams that improve the infrastructure, workflow, and processes throughout our Clinical Laboratory to accommodate rapidly growing assay volumes, an expanding test menu, introduction of new technologies and business models, expansion to multiple laboratory sites, and continuous changes in the external regulatory landscape. He or she will consult with Quality and provide guidance to the Accessioning team to address non-conformances, complaints, and CAPAs within Genomic Health's Clinical Laboratory.
The Associate Director, Pre-Analytical Laboratory will oversee the inspection preparation activities within the Accessioning department's scope of practice and ensure that all applicable regulatory requirements are met with evidence of compliance. The Associate Director will contribute to a successful inspection by interacting with the inspectors and leading operational discussions as assigned.
The Associate Director, Pre-Analytical Laboratory will interact with senior management on matters concerning Clinical Laboratory services and/or customers. The Associate Director will act as a liaison between Accessioning and various functional groups including but not limited to Histology, US and International Customer Services, Quality, Analytical Laboratory, Process and Service Engineering, Information Technology, Supply Chain Management, Workplace Services, and Pathology groups when addressing multi-disciplinary projects or issues.
In order to be successful in this highly complex work environment, the ideal candidate must demonstrate leadership, operational management, and organizational skills. He or she must have the ability to analyze complex issues and exercise judgment within broadly defined practices and policies, influence effectively to create synergy or gain acceptance of others in sensitive situations, and plan and manage multiple changing priories. The Associate Director must be able to work effectively in a dynamic interdisciplinary team environment and independently to drive results, fostering excellent communication and teamwork within the Accessioning team and at all organizational levels.


· Manage the operations of the Accessioning department including but not limited to the following: anticipating, planning for, and acquiring the required staffing, equipment, space, and workflow improvements for pre-analytical laboratory operations; monitoring quality assurance performance metrics; planning, validation and implementation of new process procedures or equipment; leading and supervision of personnel; managing resources, project timelines and deliverables
· Lead the Accessioning team through subordinate management staff and with direct management responsibilities including but not limited to recruitment, goal setting, professional development, mentoring, training and competency assessment, performance assessments and compliance
· Lead and maintain the engagement of staff and project team members, practicing above-the-line communication to create a culture of accountability, and encouraging activities to foster team building
· Collaborate with other functional groups to capture and analyze actionable data, to identify, design and implement new processes and practices, based on evidence, for continuous improvements and to achieve performance targets
· Ensure the consistency of information from test order forms and labels on patient samples, and ensure the timeliness, accuracy, and appropriate documentation of all quality-related activities specified in the Quality Management System
· Ensure consistent compliance with all applicable federal, state, local and international regulatory requirements and with all company policies and procedures
· Under the guidance of Quality, provide guidance to Accessioning and support personnel to ensure timely and effective investigation, documentation, corrective action, and preventive action associated with nonconformance, complaints, and CAPAs occurring within the Clinical Laboratory
· Lead cross-functional teams through improvement events with support from Engineering, Quality and other functional teams. Ensure that implementation of improvements run smoothly and that gains are sustained
· Contribute to inspection preparation efforts with Quality and various support teams. The activities include, but are not limited to, staff training, review of checklists and formulate responses, internal audits of documents and records, and mock inspections. Lead discussions with the inspectors on department operational topics, and ensure that any deficiencies or findings are addressed efficiently within the specified timeline
· Lead assigned cross-functional teams through projects that contribute to Genomic Health's key results. Ensure that business objectives are met within the timeline defined
· Establish operational objectives and assignments and delegates assignments to subordinates. Review objectives with senior management to determine success of operation
· Participate in developing, modifying and executing company policies that affect immediate pre-analytical laboratory operations and may also have company-wide effect
· Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and immediately communicating these to the appropriate management representatives as necessary to ensure prompt resolution
· Other responsibilities as assigned



· At least 12 years of relevant experience, including at least eight years in a regulated environment such as manufacturing, clinical laboratory pre-analytical sample processing, biobanking, biomedical material processing, or equivalent
· Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related fields
· At least five years of management experience with a proven track record of implementing changes, scaling operations for growth, staff development, and building successful teams
· Track record of leading process or quality improvement projects, allocating resources and prioritizing key deliverables to optimize delivery timelines while meeting all critical requirements
· Strong desire to work in a dynamic interdisciplinary team environment
· Ability to work on problems in which analysis of situations or data requires an evaluation of various factors, including the impact to service quality and test results
· Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
· Ability to effect improvements in operational performance and quality by identifying and leading beneficial changes in operational processes, behavior, physical location and layout of lab space, team structure and other efforts as assigned
· Ability to influence effectively to create synergy, prioritize projects, set goals and actions plans, implement plans and measure impact, including the ability to change the thinking of or gain acceptance of others in sensitive situations
· Ability to act as both a thought leader and operational expert around pre-analytical laboratory process and service transformation
· Ability to communicate effectively at all organizational levels and in situations requiring instruction, conflict resolution, consulting and advising, as well as effective written communication
· Ability to plan, organize, prioritize, manage multiple changing priorities, work effectively in a team or independently and drive to results with a high emphasis on quality
· Ability to integrate and apply feedback in a professional manner
· Knowledge of project management and change management methodologies and tools
· Knowledge of Microsoft Word, Excel, PowerPoint, Visio, Project, Outlook, quality and document control systems


· Knowledge of local, state, federal and international laboratory regulations, international standards for quality management systems
· Experiences in a Clinical Laboratory setting involving moderate or high-complexity laboratory tests
· Experience with one or more standard molecular biology techniques such as nucleic acid isolation, RNA/DNA quantification, PCR and RT-PCR, sequencing, and other clinical laboratory technologies
· Track record of success as a change agent, driving implementation of new processes and technologies through a combination of personal leadership and knowledge transfer, influencing and/or educating others in the benefits and implementation approaches for these changes
· Knowledge of or experience in cost-benefit analysis
· Ability to apply performance improvement tools and methodologies such as Lean, JIT, Six Sigma and Flow Manufacturing techniques, FMEA, etc.
· Project management experience
· Post-baccalaureate certificate or degree in management or related fields
· Knowledge of laboratory test billing compliance, ICD10 and CPT codes
· California Clinical Laboratory Scientist license


· Travel Requirements: Occasional Travel, less than 5%
· Standing or sitting for long periods of time may be necessary
· Some lifting (less than 5 pounds) may be necessary
· Sample processing using various types of laboratory equipment may be required
· May perform repetitious actions using lab tools
· Some time spent using near vision to view samples at close range may be required
· Use of various chemicals may be required to perform duties
· At times, stress may be experienced
· Use of computer and some time may be spent concentrating, reading, or analyzing data, or applying scientific rules
· May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation


We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.
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