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 Operational and Strategic Quality Management teams.
• Drive quality improvement initiatives and monitor quality, audit, compliance, vendor, and training metrics.
• Develop and maintain quality policies, procedures, guidance documents, training materials, and site-specific compliance controls.
• Collaborate with project, product, and platform teams to embed privacy, security, and regulatory requirements.
• Support regulatory inspections, internal and external audits, client quality documentation, system assessments, platform maintenance, and records retention.

Requirements

• Bachelor’s degree and 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, audit findings, investigations, 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.
• Strong cross-functional collaboration, strategic thinking, organization, communication, and prioritization skills.

Culture & Benefits

• Work supports clinical research and the delivery of life-changing therapies to patients.
• Collaborate with global Quality, Product, Operational, Business, project, and platform stakeholders.
• Contribute to quality excellence and continuous improvement across business operations.