What are the responsibilities and job description for the Senior Director, Laboratory position at KEDPLASMA?
Shape the future of plasma laboratory operations on a global scale. We are seeking a Senior Director, Laboratory to provide strategic and operational leadership for high-volume laboratory testing, including infectious disease screening, donor acceptability testing, serology, nucleic acid testing, specialty testing, and outsourced laboratory services. Reporting to the Global Plasma CEO, this executive-level leader will oversee end-to-end laboratory operations, drive organizational performance, ensure regulatory compliance, and lead continuous improvement initiatives across a multi-site laboratory environment. This role offers the opportunity to influence laboratory strategy, quality, innovation, and operational excellence while supporting the delivery of critical plasma-derived therapies.
What You'll Do
- Provide strategic leadership and operational oversight for laboratory testing and donor screening programs.
- Lead multiple laboratory operations, including internal, backup, and contract laboratory networks.
- Ensure compliance with all applicable regulatory, accreditation, quality, and safety requirements, including FDA, CLIA, ISO, AABB, EU, cGLP, and OSHA standards.
- Drive inspection readiness and oversee responses to audits, inspections, and regulatory reviews.
- Develop and execute laboratory strategies that align with organizational goals and support long-term growth.
- Establish scalable processes and operational frameworks that improve efficiency, service delivery, and performance.
- Monitor laboratory productivity, quality metrics, turnaround times, and operational KPIs.
- Oversee technical operations, testing procedures, quality control programs, and laboratory documentation.
- Partner with internal and external stakeholders to identify opportunities for continuous improvement and operational optimization.
- Lead the development and implementation of new testing protocols and laboratory capabilities.
- Ensure timely investigation, escalation, and resolution of atypical, out-of-specification, and non-conforming results.
- Manage departmental budgets, forecasting, financial reporting, and risk mitigation activities.
- Build, develop, and lead high-performing laboratory leadership teams.
- Oversee workforce planning, staffing, succession planning, employee development, and competency programs.
- Promote a culture of accountability, engagement, safety, quality, and operational excellence.
- Communicate organizational goals and monitor progress toward strategic objectives.
- Support executive leadership through data-driven decision making and operational performance reporting.
Qualifications
- Bachelor's degree required; preferred field of study in Science, Medical Technology, Microbiology, or a related discipline.
- Master's degree preferred.
- Minimum of 8 to 10 years of management experience.
- Minimum of 5 years of experience serving as a Laboratory Director.
- Previous multi-laboratory management experience required.
- Experience in plasma and/or blood donor screening laboratory operations strongly preferred.
- Strong knowledge of laboratory regulations, accreditation standards, and quality systems.
- Professional certifications such as MT (ASCP), MLS (ASCP), or SBB (ASCP) preferred.
- Demonstrated experience managing operational budgets and financial performance.
- Ability to lead large, complex laboratory organizations across multiple locations.
- Ability to travel up to 60% of the time, including overnight travel to laboratories, vendor sites, plasma collection centers, and company locations.
Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.