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 .
Apply tot his job
Apply To this Job
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 .
Apply tot his job
Apply To this Job