Manager, Quality Assurance
RemoteUnited States
Job Summary
Serve as the primary Quality Assurance liaison for the assigned business unit, partnering with Operational and Strategic Quality Management teams to define and execute quality strategies. Drive quality improvement initiatives, monitor performance metrics, and support business development activities through Requests for Information and quality agreements. Act as the lead QA contact for strategic clients, develop and maintain quality policies, and define site-specific regulatory requirements including business continuity plans. Deliver quality-related training, support routine reporting of audit outcomes and compliance metrics, and manage system assessments for new products. Provide QA support for platform maintenance and documentation management while ensuring privacy and security requirements are embedded in processes.
Required Qualifications
- Bachelor's degree
- 7 to 10 years of relevant experience in quality assurance, quality management, or a related field within a regulated environment
- Extensive knowledge of global GxP regulations and standards, including Good Clinical Practice (GCP), ICH E6, FDA regulations, and regional compliance requirements
- Strong understanding of clinical trial technologies, software solutions, and regulated product development environments
- Experience interpreting quality data, audit findings, investigations, and Corrective and Preventive Action (CAPA) activities
- Knowledge of privacy and security regulations, including GDPR, HIPAA, and related compliance requirements
- Demonstrated ability to work effectively within cross-functional teams while maintaining ownership and accountability for deliverables
- Strong business acumen and strategic thinking capabilities
- Excellent organizational, interpersonal, verbal, and written communication skills
- Ability to manage multiple priorities and successfully deliver against established timelines and milestones
- Experience supporting regulatory inspections, audits, supplier oversight, and quality compliance activities in a global environment
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