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InClin, Inc

Quality Assurance Manager – Clinical

InClin, Inc

. Write, revise, and review SOPs, policies, working practices, investigation reports, and quality metric trend reports .

Posted 9/17/2026full-timeRemote • California • United StatesSeniorLead💰 $109,000 - $136,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Assurance processes, including the management of electronic Quality Management Systems (eQMS), compliance with FDA regulations, and conducting audits. Proficient in developing quality metrics and delivering GCP training to ensure adherence to industry standards.

Highest-signal resume keywords
Quality Management System (eQMS)FDA RegulationsICH-GCP GuidelinesComputer System Validation (CSV)Certified Quality Auditor (CQA)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
SOP WritingAudit ManagementRoot Cause AnalysisQuality Metric DevelopmentProtocol Deviation Review
Soft Skills
CommunicationCollaborationTraining Delivery
Certifications & Qualifications
Certified Quality Auditor (CQA)RQAP-GxP Certification
Industry Keywords
PharmaceuticalBiopharmaceuticalClinical Quality21 CFR Part 11Regulatory Inspections

About the role

Key responsibilities & impact
  • Write, revise, and review SOPs, policies, working practices, investigation reports, and quality metric trend reports
  • Perform audits and maintain Annual Audit Plans for internal departments, CROs, specialty service providers, and clinical studies
  • Co-host FDA and regulatory inspections
  • Manage the company-wide electronic Quality Management System (eQMS) for Document Control, Training, Deviations, Complaints, and CAPAs
  • Oversee Computer System Validation (CSV) and Change Control Management
  • Review non-conformance situations, evaluate root causes and corrective actions, and ensure timely closure
  • Act as the designated QA Representative on clinical studies for Protocol Deviation Reviews and Risk Management
  • Develop quality indicators and metrics to monitor system effectiveness
  • Deliver GCP training sessions for internal and contract personnel

Requirements

What you’ll need
  • B.S. or advanced degree in science, nursing, or a related health sciences discipline
  • 8+ years of experience within the pharmaceutical, biopharmaceutical, or clinical quality arena
  • Strong working knowledge of FDA regulations and ICH-GCP guidelines
  • Familiarity with worldwide regulatory guidelines and 21 CFR Part 11 requirements is preferred
  • Ability to travel an average of 25% or less, primarily for required vendor or site audits
  • CQA (Certified Quality Auditor) or RQAP-GxP certification is a strong plus

Benefits

Comp & perks
  • Competitive compensation
  • Completely remote workspace
  • 401K
  • PTO
  • Health insurance
  • Vision insurance
  • Dental insurance
  • Infrastructure to support your success