Quest Diagnostics Incorporated

Director, Bioinformatics - Global Operations

Lewisville, TX, US

about 2 months ago
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Summary

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 25-35%, domestically and internationally, is required. Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets

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