Clinical Quality Compliance Manager
J
JobgetherHealthcare, Life Sciences
Working remotely within the United StatesFull-TimeManager
Salary$134,985 – $163,247
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Job Details
- Experience
- 8+ years of progressive experience in quality management; 2+ years leading quality teams
- Required Skills
- GCPRisk Management
Requirements
- Bachelor’s degree in a relevant discipline or equivalent professional experience.
- 8+ years of progressive experience in quality management within regulated industries.
- 2+ years of experience building, managing, or leading high-performing quality teams.
- Strong knowledge of regulatory frameworks including GCP, ISO 9001, 21 CFR Part 11, and life sciences compliance.
- Demonstrated experience managing clinical trial quality activities and regulated clinical operations.
- Hands-on experience administering, configuring, or scaling an electronic Quality Management System (eQMS).
- Experience managing quality processes including audits, CAPA, risk management, document control, and change controls.
- Familiarity with software quality practices, SDLC processes, and compliance for regulated digital solutions.
- Strong project management and stakeholder collaboration skills.
- Ability to travel occasionally as required.
Responsibilities
- Implement and maintain a comprehensive Quality Management System aligned with FDA, ICH, 21 CFR Part 11, and ISO 9001 standards.
- Manage and optimize the electronic Quality Management System (eQMS) including CAPA, risk management, and document control.
- Lead internal, external, and customer audits and maintain inspection readiness.
- Provide quality oversight for clinical trial activities and ensure adherence to Good Clinical Practice (GCP).
- Support software development lifecycle (SDLC) processes and integrate quality controls into engineering and product development.
- Monitor quality metrics, identify compliance risks, and implement proactive solutions.
- Mentor quality team members and support the scaling of quality capabilities.
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