Clinical Quality Compliance Manager
New
This position is remote within the United States.Full-TimeManager
Salary$134,985 and $163,247
Apply NowOpens the employer's application page
Job Details
- Experience
- 8+ years of progressive experience in Quality. 2+ years of previous experience building and leading successful teams of quality professionals.
- Required Skills
- Project ManagementGCP
Requirements
- BA or BS in a related field.
- 8+ years of progressive experience in Quality.
- 2+ years of experience building and leading successful teams of quality professionals.
- Deep practical knowledge of regulatory frameworks including GCP, ISO 9001, and 21 CFR Part 11.
- Hands-on experience administering, configuring, or scaling an eQMS in a fast-growth or startup environment.
- Experience working in regulated healthcare, life sciences, or digital health companies.
- Strong experience managing clinical trial quality execution.
- Exceptional project management, communication, and collaboration skills.
- Experience working with distributed teams.
- Ability to travel may be required from time to time.
Responsibilities
- Implement and maintain quality systems in alignment with regulatory requirements like FDA, ICH, 21 CFR Part 11, and ISO 9001.
- Manage, mentor, and support a high-performing quality team.
- Serve as primary administrator for the electronic Quality Management System (eQMS).
- Direct core QMS processes including document control, training, risk management, audits, CAPA, and supplier management.
- Provide quality oversight for clinical study development and operations to ensure GCP compliance.
- Review and approve software development deliverables and maintain SDLC processes for in-house software.
- Analyze quality metrics to identify trends, risks, and implement systemic improvements.
View Full Description & ApplyYou'll be redirected to the employer's site
