Sr. Clinical QA Auditor

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together we support innovation from concept to commercialization offering expertise in regulatory strategy clinical trial design and execution market access and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.

Overview

The Sr. Clinical QA Auditor is a critical CQA team member. We are seeking an experienced Senior Clinical QA Auditor to support and lead quality assurance activities across clinical trials within a fast-paced CRO environment. This individual will serve as a subject matter expert in GCP compliance driving audit strategy inspection readiness and continuous quality improvement across sponsors sites and internal processes.

Responsibilities and Duties

• Lead and execute GCP audits including investigator sites vendors internal systems and sponsor audits
• Plan conduct and report onsite and remote audits ensuring alignment with regulatory requirements (FDA EMA ICH-GCP)
• Design and lead mock FDA/EMA inspections and inspection readiness initiatives for sponsors and clinical sites
• Provide onsite audit support during regulatory inspections including hosting documentation and response coordination
• Provide support and guidance on GCP regulations and quality improvement initiatives.
• Perform and oversee TMF quality reviews and audits ensuring completeness accuracy and inspection readiness
• Identify compliance risks trends and gaps
• Act as a trusted advisor to sponsors providing strategic input on quality systems and regulatory expectations
• Contribute to the development and continuous improvement of QA processes SOPs and audit methodologies
• Participate in review of internal and external Quality Issues (QIs) and Corrective and Preventive Action (CAPA) plans.

Required Knowledge Skills and Experience

• Education: Bachelors degree
• Experience 510 years of experience in clinical quality assurance auditing or clinical operations within a CRO pharma or biotech environment.
• Medical device experience required
• Experience or exposure to global GCP regulations required
• Excellent oral and written communication skills and presentation skills
• Familiarity with ISO standards and EU GDPR regulations preferred.
• Familiarity with the Quality Management System including (but not limited to): quality training data management computer system validation document control change control audits and inspections quality issues and CAPA vendor management regulatory compliance and all areas of GCP.
• Proficient in all MS Office applications including Outlook and Teams.
• Experience in process improvement and project management preferred.
• Strong working knowledge of eQMS EDC eTMF Document Management and SaaS systems preferred.
• Demonstrated professional oral and written communications.
• Ability to read write speak and understand English fluently is required.

Travel Required: 30-40%

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.