Manager, Quality Assurance
At Clario , a part of Thermo Fisher Scientific, our Quality teams play a critical role in ensuring the quality and compliance of products and solutions used in clinical trials worldwide. As a Manager, Quality Assurance, you will help drive quality excellence across business operations, supporting regulatory-grade data collection and ensuring adherence to global regulatory requirements. You will collaborate with Quality Management, Product, Operational, and Business stakeholders to develop and execute quality strategies that support world-class products and solutions while advancing clinical research that improves patient outcomes.
What You'll Be Doing
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Serve as the primary Quality Assurance liaison for the assigned business unit and provide ongoing QA support.
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Partner with Operational and Strategic Quality Management teams to define and execute quality strategies that support product and business objectives.
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Drive quality improvement initiatives and support the achievement of business unit quality objectives.
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Monitor, measure, and evaluate quality performance and identify opportunities for continuous improvement.
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Support business development activities by contributing to Requests for Information (RFIs), Requests for Proposals (RFPs), quality agreements, and client quality documentation.
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Act as the lead QA contact for assigned strategic clients and provide QA support for additional clients as needed.
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Develop, revise, and maintain quality policies, procedures, guidance documents, and training materials.
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Define and maintain site-specific regulatory requirements, including local quality records, business continuity plans, and compliance controls.
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Deliver quality-related training and promote quality objectives across business units.
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Collaborate with project, product, and platform teams to ensure applicable privacy, security, and regulatory requirements are embedded in processes and controls.
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Support the routine reporting of quality performance, audit outcomes, compliance metrics, vendor audit metrics, and training metrics.
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Support internal and external inspections, audits, and regulatory interactions.
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Manage system assessments and categorization activities for new products and initiatives.
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Provide quality assurance support for platform maintenance, enhancements, documentation management, and long-term records retention activities.
What We Look For
- Bachelor’s degree required.
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7 to 10 years of relevant experience in quality assurance, quality management, or a related field within a regulated environment.
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Extensive knowledge of global GxP regulations and standards, including Good Clinical Practice (GCP), ICH E6, FDA regulations, and regional compliance requirements.
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Strong understanding of clinical trial technologies, software solutions, and regulated product development environments.
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Experience interpreting quality data, audit findings, investigations, and Corrective and Preventive Action (CAPA) activities.
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Knowledge of privacy and security regulations, including GDPR, HIPAA, and related compliance requirements.
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Demonstrated ability to work effectively within cross-functional teams while maintaining ownership and accountability for deliverables.
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Strong business acumen and strategic thinking capabilities.
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Excellent organizational, interpersonal, verbal, and written communication skills.
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Ability to manage multiple priorities and successfully deliver against established timelines and milestones.
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Experience supporting regulatory inspections, audits, supplier oversight, and quality compliance activities in a global environment.
At Clario , a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technol