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.
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 reserves the right to amend or change this job description to meet the needs of 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.
