The Senior Director, Laboratory Operations puts patients, people and science at the center of what we do at FMI. This person leads operations within FMI's high-volume Clinical Laboratory Improvement Amendments (CLIA)-certified, College of American Pathologists (CAP) accredited, and Quality System Regulated laboratory, focusing on the delivery of Next Generation Sequencing (NGS)-based assays for oncology care aimed at maximizing operational value for patients. This leader is responsible for leading a cross-functional team to ensure the highest quality of overall lab delivery. The role leads and develops a team of diverse employees. The Senior Director communicates company goals, safety practices, and deadlines to team. This position motivates team members, creates a speak up inclusive environment, assesses performance and develops people, including hiring and training.
The Senior Director and Site Head helps drive strategic initiatives that further develop a "high bar of excellence" in Lab Operations and is responsible for successful cross-site and cross-functional collaboration with members of other teams across the FMI Network (e.g., Client Services, Technology, Process Excellence, Quality, Product Development, Regulatory). This role maintains an in-depth understanding of end to end operations, patient and customer experience and relevant clinical and commercial compliance standards coupled with key strategic trends and shifts in the industry. This position has high standards of compliance, ethics and safety.
This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.
Regular onsite work at a designated FMI location is an essential function of this role.
Develop, refresh and execute on strategy for the site by partnering with other parts of the organization to establish a community presence.
Serve as operational director and provide oversight of the laboratories and assays.
Direct the activities of laboratory team members to ensure day-to-day operations are compliant with internal policies, procedures, and CLIA/CAP/FDA/ISO regulatory standards.
Ensure achievement of Key Performance Indicators and summarize productivity and process performance for presentation to senior leadership.
Develop OKRs to monitor performance of laboratory and formulate strategic plan for lab.
Provide leadership, management, and mentorship to staff of the various lab departments.
Commit to continuously improve the process by supporting or developing appropriate modifications for improvements in precision, accuracy, delivery, and cost-efficiencies.
Work with extended leadership team, Process Excellence team and outside consultants to evaluate the lab's workflow to achieve greater efficiencies, preserving the high level of patient and customer care which is currently being offered.
Support the development of new assays and technology transfer from development into the clinical laboratory ensuring planned and predictable performance.
Represent the laboratory as needed across the company.
Serve as liaison between Laboratory staff and internal/external clients.
Partner with the Quality team to review, manage, and improve, or execute Quality Assurance programs.
Develop, plan, and recommend budget, capital equipment, space, and staffing changes using Strategic Workforce Planning to accommodate a rapidly growing highly esoteric testing business.
Ensure the Laboratory staff conducts highly complex testing according to Standard Operating Procedures.
Review operational metrics prepared by product care and other data for executive management on a regular basis.
Collaborate with Supply Chain and/or Procurement to negotiate with the best in class vendors to fulfill AOP at a high level of quality and cost efficiency.
Prepare and support for inspections by regulatory authorities (cGMP, MHRA, BST, HTA, FDA, etc.).
Support QA, as needed, to evaluate vendors, support audits, recommend improvements required to meet the Laboratory Standards.
Partner with procurement to provide feedback on each vendor's service quality.
Develop strategic partnerships with cross functional internal stakeholders such as Supply Chain, QA, RA, and others to deliver reagent QC program globally.
Create innovative learning tactics to develop team members across the network.
Support learning principles to embed and foster a culture of learning.
Other duties as assigned.
Masters Degree and/or equivalent work experience
12+ years of relevant lab experience
7+ of prior work experience in a management role
Master's Degree in Biological, Chemical, Physical or Life Science
Prior professional experience working with Laboratory Information Management Systems (LIMS)
Prior experience leading projects and process improvements
Experience working in a multi-site organization
Prior experience in a complex and changing environment
In-depth understanding of policies, processes, and procedures necessary to perform high quality, high-complexity laboratory testing in regulated environments
Well-versed in laboratory practices and process improvement
Ability to focus on quality, budgeting, developing and coaching staff at all levels
Strong general leadership skills
Ability to work inlaboratory environment
Ability to lift up to 25lbs when required
Ability to work in clean room environment
Understanding of HIPAA and importance of privacy of patient data
Commitment to FMI's Values: Passion, Patients, Innovation, and Collaboration
Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
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)