Director, Bioinformatics - Global Operations

The Director, Bioinformatics - Global Operations, leads and manages bioinformatics technology operations spanning “sample-to-result” within the clinical diagnostics industry, ensuring regulatory compliance, operational excellence, and efficient support for laboratory processes.  This role requires both strategic and executional strengths in order to lead a global team responsible for incident management, capacity planning, and continuous improvement while maintaining quality and security standards in a highly regulated environment.

• Ensure sample turnaround time (TAT) and support service level agreements (SLAs) are consistently met.
• Oversee compliance with applicable regulatory and quality standards, including LDT, FDA medical device, IVDR, and other relevant regulations, ensuring proper documentation and evidence of compliance for everything in production.
• Take full ownership of incident management, coordinating with relevant stakeholders to ensure timely resolution.
• Create, maintain and optimize key operational metrics and operational dashboards to ensure continuous improvement in bioinformatics operations.
• Provide strategic and proactive leadership in capacity planning to support business growth and operational efficiency.
• Manage change control processes for production environments, ensuring smooth and compliant transitions.
• Collaborate with Corporate IT, Quality, Medical, and Lab Operations teams, to maintain infrastructure for quality and security compliance.
• Co-own technology transfer processes for new product launches in partnership with the Bioinformatics Solutions and Platform Engineering teams.
• Identify, champion, and implement quality and performance improvements for bioinformatics applications and production processes.
• Plan and manage development of product “life-cycle” updates, using Agile/Kanban or other industry standard SDLC methods
• Provide feedback to bioinformatics engineering teams and drive the implementation of quality improvement plans.
• Ensure timely and effective written escalation of critical issues.
• Lead and manage a global team of approximately 35 professionals, including 4 to 5 regional managers overseeing operations across multiple locations within US and EU.
• Establish clear goals, expectations, and performance metrics for the team to drive accountability and operational excellence.
• Mentor, train, and develop regional managers and Bioinformatics Operations personnel to build a high-performing and engaged workforce.
• Foster a culture of collaboration, continuous improvement, and innovation across teams and regions.
• Conduct regular performance evaluations, provide constructive feedback, and implement professional development plans.
• Manage hiring, onboarding, and succession planning to ensure a strong talent pipeline for BX operations.
• Implement effective communication strategies to keep global teams aligned on priorities, changes, and best practices.
• Hold staff accountable for performance, taking timely disciplinary action when necessary.

• Bachelor’s or Master’s degree in Bioinformatics, Computer Science, Computational Biology, or a related field. A PhD in one of these fields of study is preferred.
• Strong technical knowledge of bioinformatics pipelines, LIMS, variant interpretation systems, high performance computing, cloud-based infrastructure, and production system maintenance.
• Certifications in quality management, regulatory compliance, or IT service management (e.g., ITIL, CAP, or LSS).
• Extensive hands-on experience in bioinformatics technology operations within the clinical diagnostics industry.
• Proven track record of implementing industry best practices in a regulated environment.
• Strong understanding of compliance requirements for any of CAP/CLIA, IED62304 or CE standards. Regulatory and quality compliance expertise (FDA, IVDR, CAP/CLIA) is highly desirable.
• Experience with incident management, capacity planning, change management, and infrastructure maintenance.
• Demonstrated ability to lead and manage a global team, including regional managers, in a complex and dynamic environment.
• Experience in performance management, coaching, and professional development of technical teams.
• Strong problem-solving skills with a strategic and proactive mindset.
• Excellent written and verbal communication skills for effective issue escalation and stakeholder engagement.
• Experience with bioinformatics applications in clinical laboratory settings is strongly preferred.
• Knowledge of quality improvement methodologies such as Six Sigma or Lean is desirable.
• Familiarity with cloud-based bioinformatics infrastructure and security best practices.
• The ability to travel up to 25% is required.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets