This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

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.

• 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.

Qualifications

• 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.

Preferred Qualifications

• 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.

Other Job Details

• Location: Remote
• Candidate rate: Open market rate
• Docs required: ID proof will be required.
• Location: New Jersey, New Jersey (Remote)
• Employment Type: Contractor
• Minimum Experience: Manager/Supervisor