Quality Manager, Scientific Operations-Temp

Natera
United States
Workplace: HybridFull timeUSD 55 - 55Function: QA, Test & Release EngineeringExperience: 5+ yearsSkills: ["Technical writing","Attention to detail","Communication","Diplomatic enforcement","Stakeholder management"]

Own quality management for Scientific Operations, spanning Sample Management and Sample Operations. Partner with the QA team to maintain and improve the Quality Management System (QMS), including QA/QC frameworks, compliance structures, and QA/QC systems. Lead audits, SOP governance, document control, root cause analysis, CAPA, and staff training. Drive continuous improvements, ensure audit-ready documentation, and enforce data-logging quality standards in LIMS.

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FursaFursa
Natera
Natera
3 days ago

Quality Manager, Scientific Operations-Temp

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 15 hours agoStatus: Live

Job Summary

Own quality management for Scientific Operations, spanning Sample Management and Sample Operations. Partner with the QA team to maintain and improve the Quality Management System (QMS), including QA/QC frameworks, compliance structures, and QA/QC systems. Lead audits, SOP governance, document control, root cause analysis, CAPA, and staff training. Drive continuous improvements, ensure audit-ready documentation, and enforce data-logging quality standards in LIMS.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Manager level

Key Responsibilities

  • •Collaborate with the QA team to maintain and follow the Quality Management System (QMS) and ensure Scientific Operations aligns with company quality standards.
  • •Design and improve QA/QC processes across Scientific Operations by identifying gaps, implementing scalable solutions, and recommending changes to strengthen compliance.
  • •Manage day-to-day QA operations including audits, SOP governance, and document control with version control and periodic review cycles.
  • •Lead Root Cause Analysis (RCA) and CAPA processes for quality deviations, non-conformances, or audit findings.
  • •Support audit readiness by maintaining organized, traceable documentation, flag non-compliance, and partner with scientific teams to enforce data-logging standards within LIMS.
Travel: Low travel

Pay and Benefits

Salary: USD 55
Perks:Health InsuranceDentalVision401kPaid Leave

Key Requirements

  • •B.S. or M.S. in Life Sciences, or a related field.
  • •5+ years of experience in Quality Assurance or Quality Management within a biotech, clinical lab, or diagnostics setting.
  • •Hands-on CAP compliance experience, including familiarity with CAP inspection processes and checklist requirements.
  • •Deep understanding of GLP, GxP, and ISO 9001/17025 quality frameworks and their practical application in lab settings.
  • •Experience leading or supporting internal and external quality audits and driving corrective and preventive actions.
Experience:5+ years
Education:
Skills:Technical writingAttention to detailCommunicationDiplomatic enforcementStakeholder management
Certifications:ISBERBBMRI
Tech Stack:LIMS

Company Brief

Natera
Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.
Industry: Diagnostics
Company Size: Enterprise (1,001+ employees)
Revenue: USD 500M to 1B
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Carlos, United States
Founded: 2004
WebsiteLinkedIn