About the Job

The Vice President of Laboratory Operations will establish and lead operations for a new line of business at Foundation Medicine (FMI). This person will have the opportunity to work in a “green field” -- setting vision and design,  and leading implementation of a comprehensive operations strategy that supports this new portfolio of products, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease and other related applications. This role is responsible for establishing not only a high-volume, high-efficiency lab strategy, but also for setting a strategy that enables effective subsequent externalization.  This role requires expertise, creative and strategic thinking and excellent communication skills. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and FMI, operating as a single unit. This role contributes to the overall development and delivery of program strategy, provides insights for decision-making, and leads operations initiatives, and will be a core member of the leadership team.

Regular onsite work at a designated FMI location is an essential function of the role. 

Key Responsibilities

• Establish high throughput, highly automated lab laboratory operations design for new line of products, starting with a high performing proof of concept lab in Boston, with a plan to expand to other locations 
• Build and lead a high performing team 
• Build close collaborations with leaders across Roche, including, but not limited to, laboratory operations colleagues 
• Continuously identify areas for process improvement; regularly evaluate new technologies and methods that may further enhance our ability to deliver on our vision
• Manage the talent pipeline to execute the laboratory operations staffing plan and create effective leadership succession
• Ensure staffing of the clinical laboratory with appropriately credentialed technical and professional employees
• Participate in oversight for quality control and quality assurance for existing and new tests, including proficiency testing
• Establish, monitor and publish service metrics for customer satisfaction and business goals
• Author, contribute to, and review standard operating procedures (SOPs), tracking forms, training logs, change controls, non-conformance reports and investigations, and deviations or CAPA reports, as needed to support operational excellence.
• Ensure 100% compliance to data privacy, security, regulatory and quality 

Qualifications

Basic Qualifications

• Bachelor’s Degree
• 15+ years of progressive relevant work experience
• 5+ years of prior work in a leadership / management role

Preferred Qualifications

• Master's Degree in Biological, Chemical, Physical, or Life Science
• 12+ years of work experience in molecular lab settings
• 8+ years of prior work in a leadership / management role
• Experience in a CAP/CLIA laboratory environment
• Experience in high-volume reference laboratory environments
• Entrepreneurial mindset - will “roll up their sleeves” and do work that needs to be done 
• Communicates powerfully, to influence at all levels of the company
• Has a bias for action, with a “win as a team” approach
• Operates with a clear vision of what is at stake for patients
• Experience implementing highly-automated laboratory workflows
• Experience in lab operations implementation for complex diagnostics
• Setting, monitoring, and publishing results on quality, service, and cost goals
• In-depth understanding of policies, processes, and procedures necessary to perform high quality, high-complexity laboratory testing in environments regulated by CLIA and the Food and Drug Administration (FDA)
• A strong orientation towards seeking to understand customer needs and wants
• Knowledge of quality systems and ability to evaluate laboratory performance, formulate remedial action plans, and evaluate random and systematic errors as needed
• Excellent leadership, human relations and mentoring skills
• High attention to detail and the ability to adapt rapidly to changing priorities and tasks
• Strong acumen for program management and process improvement
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to model FMI's values: Passion, Patients, Innovation, and Collaboration

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