Quality Assurance Auditor, Supplier Quality (f/m/x)

Join our Hungary team as a Quality Assurance Auditor, Supplier Quality (f/m/x) in full time (40h/week) to support the supplier quality management program. Help to ensure the highest level of supplier quality and delivery, with compliance to Clario procedures and applicable regulations. Support cross functional teams in all aspects of audits and QMS activities related to supplier quality management.

What We Offer

• Competitive compensation

• Hybrid work environment (4 days in office, 1 day remote)

• Private medical coverage and MetLife protection

• SZÉP Card and telework reimbursement

• Engaging employee events and hybrid technology support

What You'll Be Doing

• Manage all aspects of audits and audit conduct.

• Plan, conduct, and report supplier audits and assessments according to Clario’s standard operating procedures (SOPs) and electronic document management system (EDMS) processes.

• Planning and communicating the supplier audit schedule.

• Maintaining supplier qualification documentation and audit files, ensuring documentation is current and complete. Providing input to the approved supplier list (ASL).

• Providing guidance to departments in performing supplier risk assessments, assisting supplier selection.

• Track supplier audit issues and CAPAs until closure. Champion timely management of supplier audit findings and CAPAs.

• Report metrics to your manager and Clario management as required.

• Ability to work with all levels of Clario and external personnel in a professional and organized manner.

• Identify and implement process improvements, with a focus on the supplier audit programs.

• Support all audit and inspection types (e.g. internal, external, supplier, regulatory inspections, registrar {ISO, SOC etc.}).

• Communicating effectively, verbally and in writing, with all internal and external clients.

• Escalating quality concerns and problems to your Manager or designees.

• Assisting your manager with identifying and implementing process enhancements to Clario’s quality systems and processes.

• Supporting Sponsor audits as needed.

• Participating in teams to provide applicable Clario QMS guidelines and support.

• Support continuous improvement program and conduct internal meetings to support management of issues.

• Support regulatory inspections, readiness, and preparation.

• Maintain Quality Service and Departmental Standards by following, developing and revising organizational Standard Operating Procedures (“SOP”).

• Contribute to team success by resolving issues, supporting colleagues, improving processes, and exploring new opportunities to add value to organization and departmental processes.

• Maintain technical and industry knowledge by attending and participating in relevant training sessions.

What We look For

• Bachelors degree, preferably in Health/Life Sciences

• 3 or more years relevant experience in areas of Quality Assurance, supplier Auditing, in regulated industries-preferably in Pharmaceutical, CRO, Biotech, or Medical device

• Certification in auditing, ISO Auditing and standards, related course curriculum (e.g. GXP), or equivalent preferred

• Possess a strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, and is competent with quality management systems (QMS)

• Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations

• Knowledgeable in ISO standards (e.g. 13485, 9001, 27001)

• Advanced skills with most common software applications (i.e., Word, Excel etc.)

• Understanding of medical or clinical trial terminology is desirable

• Work independently or with cross-functional teams, adjust to changing priorities, and maintain a professional, positive attitude

• Demonstrate excellent attention to detail, strong documentation and organizational skills, and effectively manage multiple tasks

• Strong verbal and written communication skills, problem-solving ability, goal orientation, and high-level ethics and integrity

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.