Vice President- Enterprise Laboratory Services

VP-ELS Job Description

The VP-ELS serves as the enterprise executive leader for all laboratory operations across NYBCe and its divisions, with responsibility for multi-state laboratory operations spanning New York, Rhode Island, Delaware, Missouri, Minnesota, Nebraska, and additional jurisdictions as applicable. This role will work cross-functionally to identify growth opportunities, best practices for productivity enhancements, areas for consolidation and streamlining, and drivers for sustainability. He/She is responsible for developing and implementing the strategic plan for the laboratories, including driving innovation, implementing emerging technologies, automating, and developing scalable laboratory solutions, and serving as an expert, advocate, and industry influencer in transfusion medicine and laboratory sciences.

This position reports to the Chief Operating Officer for Blood and Laboratory Operations, the Vice President, Enterprise Laboratory Services will function as the top executive leader of Enterprise Laboratory Services and will be responsible for overseeing the day-to-day operations, implementing business plans, managing the department's P&L (including revenue and operating margins), developing budgets and financial plans, and fostering a high-performance, customer-oriented culture. Together with stakeholders in quality, medical, and executive leadership, the VP-ELS will craft a strategy for laboratory testing that delivers on the mission of NYBCe and the needs of its customers. This includes maintaining strong relationships and direct interactions with hospital and laboratory customers to develop and sustain partnerships, address concerns, and ensure service expectations are met.

• Oversees all NYBCe laboratories. Ensures efficient production, technical excellence, and quality and regulatory-compliant laboratory services to deliver high-quality products and services.
• Provide strategic vision and executive leadership for Enterprise Laboratory Operations, developing and executing an integrated, multi-state laboratory strategy that aligns with NYBCe's mission, supports customer needs, drives innovation and operational excellence, and ensures long-term sustainability, quality, and growth.
• Provides leadership and guidance to the divisional laboratory leadership staff, fostering a collaborative and innovative work environment and promoting a culture of continuous improvement.
• In partnership with NYBCe and Divisions' Senior Leadership, execute comprehensive business, operational, and project support to ensure effective execution of Enterprise Laboratory Operations strategies, including developing enterprise laboratory and informatics roadmaps; identifying process, data, and technology requirements; aligning systems and platforms across laboratories; and defining milestones to achieve optimal operational, financial, and customer outcomes.
• Develop and implement a comprehensive strategic plan for the laboratories, aligning with the overall organizational goals, driving innovation within the laboratories, and exploring opportunities for the development or implementation of new technologies and methodologies to enhance testing and manufacturing capabilities and efficiencies.
• Working cross-functionally to ensure lab operations, practices, policies, and procedures are in compliance with regulatory and accreditation (FACT, ASHI, AABB) standards while maintaining the highest level of quality and accuracy.
• Stays abreast of regulatory changes and industry standards, fostering an environment of compliance with all relevant regulations and guidelines.
• In partnership with Quality and Medical, serves as an additional point of accountability for all FDA, CLIA, FACT and state Department of Health inspections, audits, and regulatory engagements across the enterprise.
• In partnership with Quality and Medical, supports enterprise-wide inspection readiness and compliance governance program, including internal audits, mock inspections, regulatory training, and risk mitigation activities.
• In partnership with Medical, supports educational programs and development of educational materials that establish NYBCe as an expert in testing and laboratory operations.
• Develops and executes a cross-functional plan with the enterprise-wide SVP/COO, Blood and Laboratory Operations, and in collaboration with the COO and CFO, to optimize customer engagement and partnerships, including the development and execution of enterprise laboratory pricing strategies that support sustainable growth, financial performance, and customer value.
• Develop enterprise-wide KPI metrics to ensure that customer experience, lab operations effectiveness, and efficiencies are benchmarked to industry standards.
• Ensures collaboration and commitment between Laboratory Operations and other departments to optimize customer engagement, partnership and exceed customer experience.
• Develops and monitors budget, including setting and meeting these targets & identifies cost-saving opportunities and implements efficient processes to maximize financial performance.
• Leads enterprise laboratory workforce planning, talent development, succession planning, and leadership development to ensure long-term organizational capability and bench strength. Lead quality management initiatives by crafting, articulating, and implementing a vision that embraces high quality standards for products and services.
• Drives engagement to create a "one" lab mindset motivating staff to do their best to help the organization achieve its objectives.
• Makes recommendations for improvements on organizational processes and practices.
• Own and ensure enterprise-wide laboratory business continuity and disaster recovery planning, including development, testing, and continuous improvement of plans to maintain uninterrupted operations, regulatory compliance, and customer service during emergencies, system outages, or other disruptive events.
• Participates in professional development by attending conferences and seminars and is an active participant in national organizations representing NYBCe as a recognized laboratory and regulatory leader.
• Travel domestically up to 25%.

Qualifications

Education:

• B.S. in Medical Technology or related field.
• Advanced degree (MBA, PhD or MD), a plus.

Experience:

• Fifteen (15) years of blood banking or comprehensive laboratory experience, with five years of progressive leadership experience.
• Demonstrated experience leading multi-site, multi-state laboratory operations in highly regulated CLIA and/or cGMP environments.
• Direct experience working with the FDA, CLIA, and state Departments of Health.
• Proven track record leading regulatory inspections, responding to findings, and successfully developing, implementing, and sustaining CAPA to closure.

Licenses / Certification:

• NYS Lab Technologist–preferred.
• MT (ASCP) certification-preferred.

Knowledge:

• Strong knowledge of FDA GMP compliance and quality, CLIA and State DOH laboratory requirements.
• Strong knowledge of U.S. Food and Drug Administration (FDA) regulations and guidance application to Blood establishments.
• Expert-level understanding of regulatory inspection processes, compliance governance, and enforcement risk management.
• Previous experience leading NY State Department of Health permitted laboratories subject to CLEP Standards, a plus.
• Working knowledge of Collective Bargaining Agreements, a plus.

Skills:

• Expert skills to interpret Federal, State, Local and international regulations, standards, technical specifications, and professional guidelines as they apply to NYBCe products and services.
• High level of interpersonal skills to handle a variety of complex issues and situations. Position requires demonstrated poise, tact, and diplomacy in dealing with a variety of staff up to and including executive leadership.
• Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
• Self-starter while working well in a strong team environment.
• Strategic thinking.
• Manages ambiguity - Operating effectively, even when things are not certain, or the way forward is not clear.
• Nimble learning - Actively learning through experimentation when tackling new problems, using both successes and failures as learning.
• Resilient - Rebounding from setbacks and adversity in difficult situation.

Abilities:

• Demonstrated operations and process leadership experience across multiple functional areas with a history of successful strategic planning and execution.
• Ability to lead in a matrix structure to achieve business goals; demonstrated financial acumen and experience developing and operating a capital budget.
• Analytical thinker who can work collaboratively to identify and resolve technical, operational, and organizational challenges.
• Visionary mindset with a proven ability to identify and implement innovative solutions.
• Proven history attracting and developing talent both within and outside direct team; ability to communicate clearly and effectively to direct and motivate team and others.

Any combination of education, training, and experience equivalent to the requirements listed above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $270,000.00p/yr. to $300,000.00p/yr. For applicants who will perform