About the Job

The Director, Site Enablement & Product Operations leads a team of experts that provide leadership and support for all Lab Operations development related aspects of the Product organization and is accountable for policies and procedures relating to Design Transfers and Site Enablement for all of FMI’s assays. This position is accountable for the success of FMI’s portfolio from concept to commercialization, including feasibility, development projects, product launches, design transfers, site enablement and commercial supply. The incumbent coordinates Product development and transfer activities with Lab Operations, Supply Chain, Client Services, Clinical Bioinformatics Operations, Quality Assurance, Regulatory Assurance, Pathology, Technology and Product Development teams. 

Key Responsibilities

• Primary operations representation in the Product organization. Represents operations interests in the planning, development, and launch of new products. 
• Ensures alignment of Product and Global Operations goals – and proactively manages conflicts and trade-off decisions when they occur. 
• Develops and implements robust and scalable Design Transfer and Site Enablement policies and procedures. 
• Ensures Design Transfer activities are completed in accordance with Stage Gate deliverables. 
• Coordinates with Site Heads and functional SMEs to ensure all Site Enablement activities are completed. 
• Ensures the compliance to regulatory (e.g. GMP) and legal requirements (occupational health and safety as well as protection of the environment) and represents the interests of Operations with internal and external parties. 
• Assists in development of and assures execution of strategic and operational plans for assigned Product groups. 
• Provides accurate and timely financial / budget information to ensure fact-based portfolio management and resource utilization.
• Ensures that optimization processes in Global Operations are continuously pushed forward and implemented. 
• Manage, mentor, and coach a technically skilled team with varying levels of experience. 
• Travel up to 30% of the time. 
• Other duties as assigned. 

Qualifications:

Basic Qualifications:

• Bachelor’s degree in relevant technical field (chemistry, molecular biology, bioinformatics etc.) and 10+ years related operations experience in a leadership role; Pharmaceutical/Healthcare Industry background; OR 
• Master’s degree in relevant technical field (chemistry, molecular biology, bioinformatics etc.) and 8+ years related operations experience in a leadership role; Pharmaceutical/Healthcare Industry background; 
• 6+ years of experience in Next Generation Sequencing with an emphasize on data and analytics 
• 5+ years of proven leadership experience 
• Demonstrated deep understanding of FDA and CAP/CLIA regulations 

Preferred Qualifications:

• Master’s degree in relevant technical field (chemistry, molecular biology, bioinformatics etc.) 
• Applied knowledge of product development processes with familiarity in the design control process 
• Ability to manage conflict and encourage collaboration, and successfully implement change 
• Demonstrated competencies in team leadership, team facilitation, and team member participation 
• Demonstrated ability to engage and deliver through indirect staff across many departments, countries, and cultures 
• Ability to deliver in a complex global organization 
• Strong communication skills (oral and written) with the ability to present at the functional and executive levels 
• Understanding of HIPAA and importance of privacy of patient data 
• Commitment to FMI values: Integrity, Courage, and Passion
   

The expected salary range for this position based on the primary location of Boston, MA is $160,000 - $200,000 per year. The salary range is commensurate with Foundation Medicine’s compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine’s benefits.

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