Bioinformatics Pipeline Validation Manager (Remote -US)
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, and leadership experience , along with a deep understanding of regulated environments such as GxP, CLIA, or CAP . Responsibilities • Lead and manage a team responsible for validation of bioinformatics pipelines used in genomics and clinical research. • Develop and oversee validation strategies, protocols, and documentation for bioinformatics workflows and software systems. • Ensure compliance with regulatory and quality standards such as GxP, CLIA, CAP, and internal validation policies. • Collaborate with bioinformatics scientists, data engineers, and quality teams to implement validated and reproducible computational workflows. • Review and approve validation documentation including validation plans, test cases, reports, and SOPs. • Drive improvements in validation frameworks, automation, and testing methodologies for bioinformatics pipelines. • Support regulatory audits and inspections by maintaining appropriate documentation and validation evidence. • Mentor and guide team members while ensuring alignment with organizational goals and project timelines. • Work closely with global teams while maintaining minimum 5 hours daily overlap with EST for collaboration. Requirements • 10+ years of experience in bioinformatics, genomics data analysis, or 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, GCP, 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 .