Associate Director, Bioinformatics Operations

Associate Director, Bioinformatics Operations page is loaded## Associate Director, Bioinformatics Operations locations:
US - WI - Madison time type:
Full time posted on:
Posted Todayjob requisition :
R26-12634
** Help us change lives
** At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
** Position Overview
** The Associate Director, Bioinformatics Operations is largely a self-directed leader responsible for the reliability, scalability, and compliane of bioinformatics pipelines and data workflows that support a high throughput clinical NGS and other advanced genomic technologies laboratory. This role oversees end-to-end bioinformatics operations from raw data acquisition through report ready outputs, ensuring that production systems meet CLIA/CAP, ISO, and internal quality requirements.

The Associate Director partners closely with the Laboratory Director, clinical lab operations, QA/RA, and IT/Dev Ops to maintain robust day-to-day operations while driving continuous improvement and supporting assay validations and change management.

As a technical and operational subject matter expert, the Associate Director provides guidance and mentorship to a team of bioinformaticians and scientists, develops and enforces SOPs and standards, and leads incident response, capacity planning, and operational readiness for audits and inspections.
** Essential Duties
** Include, but are not limited to, the following:
* Operational ownership of clinical pipelines
* Provide operational ownership of production bioinformatics pipelines for clinical NGS assays, from BCL/FASTQ through aligned data, variant calls, QC metrics, and report ready outputs.
* Ensure that routine analyses, QC checks, and automated workflows run reliably within defined SLAs for turnaround time and quality.
* Oversee monitoring of sequencing runs and pipeline performance, including review of run-level and sample-level metrics, and lead response to data quality concerns, contamination, discordance, and unexpected error patterns.
* Partner with IT/Dev Ops/HPC teams to manage compute, storage, and data transfer needs for production, including environment configuration, access control, and backup/restore processes.
* Own bioinformatics components of CLIA/CAP compliance for assigned assays, including documentation, validation reports, and ongoing quality monitoring for pipelines and associated tools.
* Lead or oversee verification and validation studies for new assays, assay updates, software changes, and instrumentation impacting bioinformatics workflows; develop study designs, acceptance criteria, and analysis plans in collaboration with Laboratory Director, R&D, QA and Lab Operations.
* Lead investigation and documentation of nonconformities, QC failures, and incidents involving bioinformatics systems; perform root cause analysis, define and implement corrective and preventive actions, and track effectiveness.
* Ensure that bioinformatics SOPs, work instructions, software design specifications, and change control records are current, complete, and aligned with regulatory requirements and internal QMS.
* Support preparation for and participation in CLIA/CAP, ISO, and other regulatory or client audits, serving as the primary bioinformatics operations representative for assigned areas.
* Provide day‐to‐day leadership to a team of bioinformatics professionals (e.g., Bioinformatician I–Principal), including workload allocation, prioritization, coaching, and performance management.
* Set clear goals and expectations for bioinformatics operations staff, conduct performance reviews, identify development needs, and support career progression consistent with the Bioinformatics Operations career ladder.
* Oversee training, competency assessment, and ongoing education for team members on production pipelines, QC practices, SOPs, and regulatory expectations.
* Foster a collaborative…