Bioinformatics Pipeline Validation Manager with Cancer genomics exp (Remote -US)

OMG Technology•Mahwah, NJ

34d•Remote

About The Position

We are seeking an experienced Bioinformatics Pipeline Validation Manager to lead validation efforts for bioinformatics pipelines. This individual will manage a team responsible for ensuring that computational pipelines used in genomics and clinical research meet regulatory, quality, and performance standards. This role is within a life sciences organization focused on advancing molecular diagnostics and genomic technologies. The ideal candidate will bring strong bioinformatics, NGS pipeline validation, Cancer genomics experience and leadership experience, along with a deep understanding of regulated environments such as GxP, CLIA, or CAP.

Requirements

10+ years of experience in bioinformatics, genomics data analysis, cancer genomics exp pipeline validation.
4+ years of leadership or management experience leading technical teams.
Strong experience with NGS data processing pipelines, including quality control, alignment, variant calling, annotation, and interpretation.
Hands-on experience with bioinformatics workflow management tools such as Nextflow, Snakemake, WDL, Cromwell, or Galaxy.
Experience with common NGS analysis tools such as BWA, Bowtie2, GATK, SAMtools, Picard, FastQC, MultiQC, and VEP/ANNOVAR.
Experience with containerization and reproducibility tools such as Docker, Singularity/Apptainer, and workflow environment management tools like Conda or Bioconda to ensure reproducible bioinformatics pipelines.
Proficiency in scripting or programming languages such as Python, R, or Bash.
Experience working in regulated environments (GxP, CLIA, CAP, or similar).
Familiarity with software validation lifecycle, automated testing, and documentation practices.
Bachelor’s or master’s degree in bioinformatics, Computational Biology, Genomics, Computer Science, or related field.

Nice To Haves

Experience supporting clinical genomics or diagnostic pipelines.
Knowledge of cloud platforms such as AWS, Google Cloud Platform, or Azure used for scalable bioinformatics workflows.
Experience with CI/CD tools such as Jenkins, GitLab CI, or GitHub Actions.
Experience managing large-scale genomic datasets and distributed computing environments.

Responsibilities

Lead, mentor, and develop a team of bioinformatics validation scientists and analysts.
Oversee workload planning, project assignments, and team performance tracking.
Foster a collaborative, high-performing team culture focused on quality, efficiency, and innovation.
Own end-to-end validation of bioinformatics pipelines, including NGS, WGS/WES, RNA-seq, variant calling, annotation, and QC workflows.
Develop and execute validation plans, protocols, test cases, and acceptance criteria.
Ensure pipelines meet applicable regulatory requirements (e.g., CLIA, CAP, FDA).
Perform software verification and validation (SV&V) and document results thoroughly.
Collaborate with bioinformatics engineers, data scientists, and software developers to optimize pipeline design and performance.
Evaluate new tools, algorithms, and software for integration into analytical workflows.
Troubleshoot pipeline issues and lead root-cause analysis efforts.
Ensure reproducibility, scalability, and robustness of computational workflows.
Partner with wet lab teams, QA, clinical operations, and product management to align validation objectives with timelines and business goals.
Represent the validation team in client meetings, audits, and technical reviews.
Maintain detailed documentation of validation activities, including version control and release notes.
Prepare documentation for regulatory submissions and internal audits.
Establish and enforce validation standards, SOPs, and best practices.