Manager, Quality Assurance

Location: United States Remote

Company

hirify.global, part of Thermo Fisher Scientific, develops products and solutions that support clinical trials and regulatory-grade data collection.

What you will do

• Act as the primary Quality Assurance liaison for an assigned business unit and strategic clients.
• Define and execute quality strategies with Quality Management, Product, Operational, Project, and Business stakeholders.
• Monitor quality performance, audit outcomes, compliance metrics, vendor oversight, and training metrics.
• Develop and maintain quality policies, procedures, guidance documents, training materials, and regulatory records.
• Support internal and external inspections, audits, regulatory interactions, system assessments, and product categorization.
• Ensure privacy, security, regulatory, documentation, platform maintenance, and long-term records-retention requirements are embedded in controls.

Requirements

• Bachelor’s degree.
• 7–10 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 GCP, ICH E6, FDA regulations, and regional compliance requirements.
• Experience with clinical trial technologies, software solutions, regulated product development, quality data, investigations, audit findings, and CAPA activities.
• Knowledge of privacy and security regulations, including GDPR and HIPAA.
• Experience supporting regulatory inspections, audits, supplier oversight, and quality compliance in a global environment, with strong cross-functional communication and organizational skills.

Culture & Benefits

• Medical, dental, and vision insurance beginning on the first day of employment.
• Flexible work schedules and remote working.
• Attractive paid time off plan.
• Competitive compensation and employee programs.
• Work focused on advancing clinical research and helping bring therapies to patients faster.