Bioinformatics Pipeline Validation Manager
We are looking to hire a candidate with the skills sets mentioned and experience for one of our clients within the life science Industry.
Location: Flexible (Remote) – Must overlap at least 5 hours with EST daily
Job summary
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.
Key Responsibilities
Leadership & Team Management
• 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.
Pipeline Validation & Quality Assurance
• 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.
Technical Expertise & Execution
• 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.
Cross-Functional Collaboration
• 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.
Documentation & Compliance
• 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.
Required Qualifications
• Master’s or Ph.D. in Bioinformatics, Computational Biology, Genomics, Computer Science, or a related field.
• 6–10+ years of industry experience in bioinformatics, including pipeline development or validation.
• Strong understanding of NGS technologies and analytical methods (e.g., alignment, variant calling, QC metrics, annotation tools).
• Experience validating bioinformatics tools in regulated or semi-regulated environments.
• Proficiency with workflow management systems (e.g., Nextflow, Snakemake, WDL/Cromwell).
• Programming experience in Python, R, or Bash.
• Familiarity with cloud-based environments (e.g., AWS, Azure, GCP) is a strong plus.
• Proven people management or technical leadership experience.
Other Job Details:
• Location: Remote
• Candidate rate: : $65 on C2C and $60 on W2
• Docs required: ID proof will be required.