Exact Sciences Corporation

Sr Manager, Pre-Analytical Laboratory Services

Job Locations US-CA-Redwood City
Req No.
2020-5434
Category
Clinical Lab Operations
Type
Regular Full-Time

Summary of Major Responsibilities

The Sr. Manager, Pre-Analytical Laboratory Services will oversee the operations of Exact Sciences’ Accessioning department in Redwood City 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 Sr. Manager will lead the Accessioning department through projects and improvement activities that contribute directly to Exact Sciences’ key results, ensuring budgets, project schedules and business requirements are met.

 

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 Sr. Manager 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 Exact Sciences’ Clinical Laboratory in Redwood City.

 

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 Sr. Manager 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.

Essential Duties and Responsibilities

Include but not limited to the following

  • 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 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.
  • 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.
  • Lead or participate in Accessioning process improvement activities 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.  Support discussions with the inspectors on department operational topics and ensure that any deficiencies or findings are addressed efficiently within the specified timeline.
  • Participate in developing, modifying, and executing company policies that affect immediate pre-analytical laboratory operations and may also have company-wide effect.
  • 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 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.
  • 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.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Ability to lift up to 5 pounds for approximately 5% of a typical working day.
  • Ability to work seated for approximately 75% of a typical working day. Ability to work standing for approximately 25% of a typical working day.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
  • May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation.
  • Use of computer, and or phone for long periods of time may be necessary, and considerable periods of time may be spent concentrating, reading, or analyzing data, or applying scientific rules.
  • May perform repetitious actions using lab tools.
  • Some time spent using near vision to view samples at close range.
  • Use of various chemicals may be used to perform duties.
  • Ability and means to travel between (either Madison or Red Wood City) locations.
  • Ability to travel <5% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science, or related field.
  • 10+ years of relevant experience to include
    • 8+ years in a regulated environment such as manufacturing, clinical laboratory pre-analytical sample processing, biobanking, biomedical material processing, or equivalent.
    • 5+ years of experiences in leading process or quality improvement projects, allocating resources and prioritizing key deliverables to optimize delivery timelines while meeting all critical requirements.
  • 5+ years of management experience with a proven track record of implementing changes, scaling operations for growth, staff development, and building successful teams.
  • Knowledge of Microsoft Word, Excel, PowerPoint, Visio, Project, Outlook, quality, and document control systems.
  • Authorization to work in the United States without sponsorship.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

  • 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.

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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