Manager Quality Assurance

At [Clario](https://himalayas.app/companies/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 * Serve as the primary Quality Assurance liaison for the assigned business unit and provide ongoing QA support. * Partner with Operational and Strategic Quality Management teams to define and execute quality strategies that support product and business objectives. * Drive quality improvement initiatives and support the achievement of business unit quality objectives. * Monitor, measure, and evaluate quality performance and identify opportunities for continuous improvement. * Support business development activities by contributing to Requests for Information (RFIs), Requests for Proposals (RFPs), quality agreements, and client quality documentation. * Act as the lead QA contact for assigned strategic clients and provide QA support for additional clients as needed. * Develop, revise, and maintain quality policies, procedures, guidance documents, and training materials. * Define and maintain site-specific regulatory requirements, including local quality records, business continuity plans, and compliance controls. * Deliver quality-related training and promote quality objectives across business units. * Collaborate with project, product, and platform teams to ensure applicable privacy, security, and regulatory requirements are embedded in processes and controls. * Support the routine reporting of quality performance, audit outcomes, compliance metrics, vendor audit metrics, and training metrics. * Support internal and external inspections, audits, and regulatory interactions. * Manage system assessments and categorization activities for new products and initiatives. * Provide quality assurance support for platform maintenance, enhancements, documentation management, and long-term records retention activities. ### What We Look For * ### Bachelor’s degree required. * 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. At [Clario](https://himalayas.app/companies/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 technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster. _The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. [Clario](https://himalayas.app/companies/clario) reserves the right to amend or change this job description to meet the needs of [Clario](https://himalayas.app/companies/clario). This job description and any attachments do not constitute or represent a contract. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications._ Originally posted on [Himalayas](https://himalayas.app)