The Strategic Operations Manager performs a range of management activities supporting all functions of FMI’s Strategic Operations department. The role of the Strategic Operations department is to translate corporate objectives into strategy & functional objectives for Global Operations and subsequently in concrete actions for impacted functions, including ownership of projects and controlling of outcomes. The incumbent coordinates projects within Strategic Operations and with Lab Operations, Supply Chain, Client Services, Genomic Analysis and Reporting, Quality Assurance, Regulatory Assurance, Pathology, Technology and Product Development teams. This role is responsible for supporting and leading projects across all functions as needed.
Key Responsibilities
Support all functions of Strategic Operations (Process Excellence, Services Transformation, Assay Excellence, Product Operations) in critical project phases.
Collaborates with the Product Development, Process Engineering, Technology, Development Operations, Laboratory Operations, Bioinformatics, Quality Assurance and Regulatory teams to assist with assay and process development.
Participate in or lead departmental or cross-functional projects and initiatives as assigned.
Present data, proposals, and progress to internal and external team members.
Contribute to and execute a continuous improvement strategy for all department processes and procedures.
Contribute to the development and execution of department goals and initiatives.
Drive research of new equipment and processes, including market analysis and cost calculations.
Head the Avenio Tumor Tissue CGP Kit Peer-to-Peer program, including support of existing customers, onboarding of new customers, maintenance of existing packages and development of new packages.
Delivers timely and innovative solutions to address customer needs in inter-departmental collaboration with Research and Development, Commercial, Clinical, Quality Assurance, Business Development, and other teams as needed.
Accountable for the support of cross-functional business and technology process improvements.
Other duties pertinent to Strategic Operations as occasionally assigned.
Position requires ability to travel internationally (up to 20%).
Qualifications
Basic Qualifications
Master’s degree or equivalent in Biology or Life Sciences
5+ years of experience working in a professional life sciences environment or field in a regulated laboratory environment (e.g. ISO 15189)
Preferred Qualifications
5+ years of experience working in a professional life sciences environment or field in a regulated laboratory environment (e.g. ISO 15189)
Demonstrated ability with project management, organizational and planning
Demonstrated ability to effectively organize and execute tasks
Demonstrated ability to work well under pressure while maintaining a professional demeanor
Experience in the verification and implementation of ISO 15189-certified tests including writing SOPs and verification plans/reports
Demonstrated scientific background and capability to conduct and coordinate verification studies and summarizing data for internal and external presentations
Highly effective teamwork and collaboration skills in a dynamic and international environment
Ability to work independently and with a team under fast-paced and changing conditions
Understanding of HIPAA and importance of patient safety and data privacy regulations and guidelines
Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
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