Sr. Quality Assurance Auditor

Ready to make an impact in clinical research?

Join Clario and elevate quality and compliance across our clinical services. In this role, you’ll lead advanced quality audits and assessments of Clario’s procedures, systems, and data to ensure regulatory compliance and the highest standards of service delivery.

What We Offer

• Competitive compensation and incentives

• Private medical coverage and MetLife protection

• SZÉP Card and telework reimbursement

• Flexible time off

• Engaging employee events and hybrid technology support

What You’ll Be Doing

• Performs internal/supplier audits, quality reviews and gap analyses of Clario’s operational and technical departments, processes and systems to ensure

• Compliance with Clario SOPs, Good Clinical Practices, and EN ISO 9001/ISO 13485 and applicable regulatory requirements. Includes all processes related to Clario’s System Development Life Cycle, Operations, and Quality Management System

• Effectiveness of supplier Quality Management Systems, and their ability to meet Clario contractual agreements, Clario quality standards, and applicable regulations

• Identification of potential/realized risks and determination of systemic approaches to effectively correct and prevent issues from recurring through utilization of risk based and control concepts

• Data, processes, and systems implemented by Clario are compliant with applicable regulations, guidelines, and internal procedures through quality reviews of primary study documentation and software applications

• Manages multiple QA tasks in parallel and effectively prioritizes tasks to align with corporate quality objectives. Coordinates intra/interdisciplinary personnel through scheduled meetings and written communications, effective time management, tracking deliverables and when necessary, escalations to supervisor

• Acts in leadership role for joint department/supplier auditing efforts with other QA Audits and oversees activities including

• Develops auditing plans and compiles reports for assigned audits at a level that requires minimal feedback from Quality Assurance Management

• Reviews audit plans and reports developed by other QA Auditors and provides mentoring and feedback for development of their writing skills

• Assigns and manages tasks to ensure that the audit is conducted efficiently and effectively

• Oversees the mitigation and closure of observations by conducting proactive follow-up with the applicable departments to ensure timelines for corrective/preventative actions are met

• Performs tracking/trending analysis of audit findings

• Executes audits in compliance with the Annual Audit Schedule and completes reports within the timelines defined by Clario SOPs

• Acts in hosting role for management of client audits. 

• Ability to demonstrate knowledge of Clario’s quality management system, regulatory requirements, business line products/services, and organizational structure

• Acting as the liaison between Clario and the client and coordinating with applicable department representative when their participation is required

• Effective distribution of audit requests and communications with auditors to address concerns

• Successful client audit outcomes; tracking/trending analysis of audit findings within the quality management tool

• Analysis of observations identified; ability to oversee and work collaboratively with applicable departments to generate effective corrective and preventative action responses

• Oversight of mitigation and closure of observations; conduct follow-up with the applicable department to ensure time limes for corrective/preventative actions are met. 

• Effectively communicate mitigation to clients

• Supports Continuous Improvement Program through:

• Effective investigation of issues and complaints including collaboration with applicable department head(s)

• Facilitation of root cause analysis to determine appropriate corrective and preventative actions

• Management of Issues and Actions in quality management tool

• Development of the Continuous Improvement Committee agenda

• Ability to oversee department initiatives effectively to support improved Quality Management functions such as document management, process development/management and QA tool administration

Other responsibilities:

• Authors Quality Assurance/Regulatory Affairs standard operating procedures as required

• Trains QA personnel on advanced concepts on auditing, quality management, or regulatory principles

• Provides Annual Quality Assurance/Regulatory Affairs Training Courses to Clario staff, as necessary

• Provides consulting services to contracted external sources as required

• Assists in the development or execution of system testing as required

• Participation in this task may only occur if the Quality Assurance Auditor is not assigned to the project in an audit role

What We Look For

• College Degree in Health/Life Sciences

• 5-7 years’ experience in a Quality Assurance capacity with a focus on GCPs and previous auditing experience; GMPs experience with medical devices is a plus

• Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities

• Excellent leadership, analytical, organizational, and communication skills

• Detail oriented

• Ability to write concise and accurate audit reports

• Competent in Microsoft Office, especially spreadsheets, database and reporting tools; experience with CAPA Management systems desired

• Ability and willingness to travel at least 10-15% of the time (international and domestic)

• Ability to exercise good judgment, tact, and confidentiality in all matters

At Clario, 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.