Clario, part of Thermo Fisher Scientific, is seeking a Quality Assurance professional to support and strengthen the integrity of our clinical studies through effective quality systems and continuous improvement. Working at the core of our Quality Management System (QMS), this role partners closely with Clinical Operations, Data Management, and Safety teams to manage Quality Events, CAPAs, and quality metrics that directly impact study conduct, data quality, and participant safety. This position plays a key role in ensuring compliance within FDA‑regulated environments while helping transform lives through better evidence.
What You’ll Be Doing
Generate quality metrics and support process improvement initiatives within the Quality Unit
Implement and maintain Quality Management Systems (QMS)
Manage CAPA responses for internal/vendor audits and external audit observations; ensure timely follow-up
Develop and distribute KPIs and other key quality metrics
Create documentation for new workflows, procedures, training, and support materials
Assist with updates to Standard Work Instructions and SOPs
Prioritize multiple QA tasks to align with corporate quality objectives
Track deliverables and escalate issues when necessary
What We Look For
Advanced professional proficiency in English (oral and written) – mandatory
Bachelor’s degree in a scientific or technical field
2–5 years of experience in a Quality Assurance role within an FDA-regulated environment
Knowledge of GDP, GCP, and regulatory frameworks (21 CFR Part 11, 21 CFR 820.20, ISO 9001/13485)
Experience with QMS and CAPA processes
Proficiency in Excel
Strong attention to detail and organizational skills
Ability to work independently and collaboratively
Skilled in editing, proofreading, and clear documentation
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.
Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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.
