Genomic Health, Inc.

Genomic Health, Inc., a life science company founded in August of 2000 and located in Redwood City, California, conducts sophisticated genomic research to develop clinically validated molecular diagnostics, which provide individualized information on the likelihood of disease recurrence and response to certain types of therapy. These diagnostic technologies generate information that healthcare providers and patients can use in making treatment decisions.

Software Quality Assurance Lead – Medical Devices and Quality Systems (LIMS)
Job ID:  1274

Overview

As a member of the Software Quality Assurance (SQA) team in the Software Engineering group, the Software Quality Assurance Lead - Medical Device and Quality Systems (LIMS) will lead the SQA effort for custom-built medical device and quality system software. The SQA Lead will serve as a technical expert on regulatory policies and programs, lead cross-functional SQA team meetings, participate in Risk/Hazard Analysis, plan, coordinate and execute on all SQA activities defined in the Engineering Development Plan, work with software development and project teams on system design, and supervise SQA Engineers assigned to all LIMS releases. The SQA Lead is expected to have significant project management experience in an FDA regulated environment. This is a position with opportunity for significant visibility and impact in an innovative and dynamic cancer diagnostics company.

Responsibilities

• Provide guidance on the application of the GHI Software Development Lifecycle (SDLC) and other validation policies
• Provide guidance to project teams on Engineering deliverables for change control of existing systems and implementation of new systems
• Plan, staff and manage all SQA activities for all LIMS releases
• Perform or provide independent oversight of the generation and execution of Engineering documentation (development plans, user/functional requirements, design specifications, risk analysis, scripts, protocols and test plans, etc.) for LIMS releases
• Interface with User Groups to establish software intent of use requirements
• Review Engineering documentation in accordance with GHI policies
• Interact and communicate effectively with other departments, system owners and users, outside vendors and contractors to successfully complete SQA activities for all LIMS releases
• Work collaboratively with program management and IT on the prioritization, development, implementation and maintenance of LIMS systems
• Supervise SQA Engineers assigned to all LIMS release
• Provide training on protocols and SOPs
• Actively participate in testing
• Support Corporate QA and Regulatory Affairs as required or requested
• Participate in audits of computerized system suppliers and software vendors as required or requested

Qualifications

• Demonstrated ability to apply software development principles and concepts to meet regulatory and industry expectations
• Demonstrated track record for planning, executing and managing SQA activities in an FDA regulated environment and driving projects to closure
• Several years of hand-on testing experience (manual and automated)
• Demonstrated ability to take a critical thinking approach to SQA that results in an efficient, value-added process that also meets regulatory requirements
• Demonstrated ability to influence project teams and individuals on SQA matters
• Experience leading small teams (4-10 SQA Engineers)
• Proven ability to learn and understand complex laboratory software
• Excellent conflict resolution skills
• Excellent problem solving and analytical skills
• Excellent verbal and written communication skills
 
REQUIRED EXPERIENCE, EDUCATION AND/OR LICENSES/CERTIFICATIONS

• 6+ years experience in Software Quality Assurance in the biotechnology or pharmaceutical industry, with 2+ years in a Management/Lead capacity
• Knowledge of 21 CFR Part 11 and other FDA regulations
• Experience with Process Automation Systems, Laboratory Information Management Systems and Instrument Software
• BS in Computer Science, Engineering or other technical field

For Immediate consideration, please apply directly to our website at:  https://jobs-genomichealth.icims.com/genomichealth_jobs/jobs/candidate/job.jsp?jobid=1274&mode=view